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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, HIV Infections Pneumocystis Pneumonia Emphysema Chronic Obstructive Pulmonary Disease Asthma Subject is Male / Female 18years of age or older Subject has been previously determined to be HIV-infected or has been participating in the Pitt Men's study or is seen at the UPMC HIV/AIDS program Subject is experiencing acute onset of shortness of breath, cough, fevers or heart conditions problems such as tachycardia, angina or arrhythmias Female subject has told us she is pregnant (this might affect pulmonary function values,we will not require pregnancy testing.) Subject has had an MI, CVA, or cardiovascular event within the past 3 months Subject has had eye or abdominal surgery within past 3 months | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease COPD patients on necessity of long-term oxygen therapy Patients treated by LTOT, with or without clinically fulfilled for LTOT, with PaO2<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56% Patient clinically stable Patient with oxygen device of network Oral and written consent Patient with obstructive sleep apnea or overlap syndrome Patient with non invasive ventilation Patient with evolutive cancer Inability to complete questionnaires Inability to attend outpatient clinic | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Dyspnea Heart Failure Asthma COPD patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) age <18 years history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea pneumonia pulmonary embolism carcinoma pneumothorax pleural effusion intoxications (drugs) anaphylactic reactions upper airway obstruction | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Atrial Fibrillation Patients undergo valvular surgery and/ or coronary surgery All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation Patients have given written informed consent Patients who do not speak Dutch or can not read Dutch Patients with a Sick Sinus Syndrome Patients with contraindications for oral anticoagulant agents Incompetent to act for oneself | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Key Male or female patients ≥18 years of age with a current diagnosis of pulmonary arterial hypertension (PAH) according to the Dana Point 2008 Meeting: World Health Organization (WHO) Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) or Posterior Descending Artery (PDA)], or PAH associated with diet therapies or other drugs A Pulmonary Vascular Resistance (PVR) ≥ 800 dynes.sec.cm-5 (as assessed by Right Heart Catheterization (RHC) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific PAH therapies, including Endothelin Receptor Antagonists (ERAs), phosphodiesterase 5 inhibitors (PDE5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. Background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment) World Health Organization functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues WD ≥ 150 meters and ≤ 450 meters at screening. Distances of two consecutive 6MWTs were to be within 15% of one another. Key With a pulmonary capillary wedge pressure > 15 mm Hg to rule out PAH secondary to left ventricular dysfunction With a diagnosis of pulmonary artery or vein stenosis Left ventricular ejection fraction (LVEF) < 45% With Disseminated Intravascular Coagulation (DIC) With evidence of major bleeding or intracranial hemorrhage With a history of elevated intracranial pressure With a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa With a QTcF > 450 msec for males and > 470 msec for females at screening and baseline in the absence of right bundle branch block With a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter With a history of Torsades de Pointes | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Agoraphobia Patients ages 18 years or older Patients with agoraphobia Patients with a score on Mobility Inventory "Alone" of 2.5 or more Patients who give a written consent to participate Psychosis (past or present) Drug abuse or dependency Moderate or high score on suicidal behaviour on the M.I.N.I Patients who have another illness (other than panic disorder or agoraphobia) and are in need of immediate treatment | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 50.0-999.0, Diastolic Heart Failure Hypertensive Heart Disease Satisfy European Society of Cardiology guidelines for the diagnosis of HF-PSF (Paulus WJ et al. Eur. Heart J. 2007;28:2539-2550) Framingham for heart failure satisfied left ventricular ejection fraction ≥ 50% (contrast ventriculography, echocardiography, nuclear scintigraphy) Diastolic dysfunction on previous echocardiogram/catheterization or evidence of abnormal neurohormonal activation (B-type natriuretic peptide (BNP) ≥ 100 pg/ml) with supporting evidence (atrial fibrillation, left atrial enlargement, left ventricular hypertrophy) History of systemic hypertension Willing to adhere to provided diet New York Heart Association Class IV heart failure symptoms Hospitalization for decompensated heart failure within past one month Uncontrolled hypertension (seated systolic blood pressure ≥ 180 or diastolic blood pressure ≥ 110) at rest, on current antihypertensive regimen Changes in medical regimen for heart disease or hypertension within past 1 month, including diuretic dose adjustment Primary exercise limitation due to severe pulmonary disease Poor echocardiographic windows Worse than moderate mitral or aortic stenosis or insufficiency Serum potassium level > 5.0 mmol/L at baseline or prior history of serum potassium level > 6.0 Serum calcium/phosphorus product > 50 at baseline Severe renal insufficiency (current estimated glomerular filtration rate < 30 ml/min) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Subjects aged 18 and over who have any of the following conditions Idiopathic pulmonary arterial hypertension PAH associated with connective tissue disease (CTD) PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window. 2. Subjects with a mean pulmonary artery pressure (mPAP) > 25mmHg and a pulmonary artery wedge pressure (PAWP) < 15mmHg at rest, assessed via right heart catheterization. 3. Subjects whose baseline 6-min walk test distance was > 100m and < 450m PAH secondary to any etiology other than those specified in the criteria. 2. Subjects with congenital heart disease (other than those specified in the criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure. 3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 17.0-999.0, Sickle Cell Anemia Pulmonary Hypertension patients with Sickle Cell Anemia homozygous to hemoglobin S preserved physical capacity steady state of the disease Pulmonary Hypertension at rest Recent sickling crisis(<2 months) High Blood Pressure Atrial fibrillation Chronic obstructive pulmonary disease Last blood transfusion > 3 months before Signs of congestive heart failure or significant valve disease Normal global and regional systolic function on echocardiography | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 35.0-74.0, Asthma Asthma patients with stable persistent asthma Current inhaled corticosteroid users On maintenance oral steroid Systemic steroid use in recent 1 month Asthma exacerbation (GINA criteria) in recent 1 month (ie daytime or nocturnal symptoms increment, detectable wheezing on physical examination, drop in peak flow rate, drop in spirometry indexes, increase in asthma medication, emergency medical attendance for asthma, days off work for asthma etc) Inhaled corticosteroid use for < 6 months Pregnancy | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-85.0, Subclinical Hypothyroidism Subjects with subclinical hypothyroidism Patients taking L-thyroxin therapy Patients with known cardiovascular, cerebral or peripheral atherosclerotic disease | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 30.0-999.0, Dyspnea Any patient able and willing to cooperate with the study and who defines themselves as breathless at rest by answering 'yes' to the question, 'Do you currently feel short of breath?' Any diagnosis causing breathlessness Age >3 0years Patients who have previously used a handheld fan to manage their breathlessness Patients with fever >38 0C in last 24 hours Patients on continuous oxygen Patients requiring short burst oxygen therapy whilst completing the study Patients with diseases or treatment affecting the trigeminal nerve supply Patients with other diseases which, in the opinion of the researcher or investigator, may affect the mechanism of action of the fan Patients unable to understand or cooperate with study Patients who do not wish to participate in the study | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80%predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70 Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospitalizations in the preceding 6 weeks A cigarette smoking history ≥ 20 pack-yrs Body mass index between 18.5 and 30 kg/m2 Able to perform all study procedures and provide informed consent A diffusing capacity of the lung for carbon monoxide (DLCO) < 40 %predicted Presence of active cardiopulmonary disease (or comorbidities) other than COPD that could contribute to dyspnea and exercise limitation Clinical diagnosis of sleep disordered breathing History or clinical evidence of asthma Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s) Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) We define advanced COPD as including those with severe COPD by CTS (i.e., severe shortness of breath resulting in the patient being too breathless to leave the house, or breathlessness after dressing/undressing (i.e., Medical Research Council (MRC) score of 5), or the presence of chronic respiratory failure (PaCO2>45) or clinical signs of right heart failure) We will also patients who are short of breath and stop walking after about 100 meters or a few minutes on the level (MRC score 4) with at least one the following BMI < 21 post-bronchodilator FEV1 < 30% predicted one or more hospital admissions for acute exacerbation of COPD in the previous year MRC 4 patients will be recruited only if their baseline Chronic Respiratory Questionnaire dyspnea domain (CRQ-D) score is < 5, an entry criterion used in a Canadian RCT involving patients with advanced lung disease Patients and/or caregivers with cognitive or other difficulties that would preclude questionnaire completion Inability to speak or understand English Patients considered to be dying or with an expected survival of less than 2 months | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Male and female subjects 18 years of age or older with symptomatic PAH despite treatment with anticoagulants, calcium channel blockers, diuretics, cardiac glycosides, supplemental oxygen, endothelin-receptor antagonists and/or phosphodiesterase inhibitors. Endothelin receptor antagonists and phosphodiesterase inhibitors must have been used at a stable dose for more than 12 weeks before screening. 2. Subjects with idiopathic PAH, familial pulmonary arterial hypertension and PAH associated with collagen vascular disease, corrected congenital vitium (congenital systemic to pulmonary shunts surgically repaired at least five years before) or anorexigen use. 3. Diagnosis of PAH established according to the standard 1. Resting mean pulmonary arterial pressure > 25 mmHg. 2. PVR > 240 dynes s/cm5. 3. Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg. 4. PVR > 400 dynes s/cm5. 5. Two 6MWTs between 150 and 500 m (inclusive) with the variation in 6MWT within ± 15% between the two tests despite other treatments for PAH Two 6MWT values are needed. Only one 6MWT should be performed at screening for confirmation of if 6MWT has been previously conducted within six weeks of the screening visit unless the subject was taking another investigational drug or participating in a specific training and exercise programme at the time of the previous test. 6. Subjects who are able and willing to refrain from sunbathing, prolonged sun exposure, and solarium use, and to limit skin and eye exposure to sunlight using appropriate precautions (protective clothing, sunscreen and sunglasses) from the first dose until 14 days after study drug discontinuation Subjects will not be entered in the study for any of the following reasons: 1. Subjects with clinically unstable right heart failure within the last three months (NYHA Class IV). 2. Subjects who have received or have been scheduled to receive long-term treatment with epoprostenol within three months before screening. 3. Hypotensive subjects (systemic systolic blood pressure < 85 mmHg). 4. Subjects with PAH associated with portal hypertension, Human Immunodeficiency Virus infection or unrepaired congenital systemic to pulmonary shunts. 5. Subjects with ventilation-perfusion lung scan or pulmonary angiography indicative of thromboembolic disease. 6. Subjects with significant obstructive (forced expiratory volume in one second [FEV1]/forced vital capacity [FVC] < 70% predicted) or restrictive (total lung capacity < 70% predicted) lung disease. 7. In collagen vascular diseases, subjects with significant interstitial disease (FVC < 70% predicted). 8. Subjects with evidence of left sided heart disease. 9. Subjects with moderate or severe hepatic impairment (Child-Pugh B and C). 10. Subjects with clinically significant chronic renal insufficiency (estimated creatinine clearance < 30 mL/minute, or serum creatinine > 2.5 mg/dL). 11. Subjects who are receiving or have been receiving any investigational drugs within 30 days before screening. 12. Subjects with musculoskeletal disorder limiting ambulation. 13. Females who are breast-feeding, pregnant or plan to become pregnant during the study and females who are not using a highly effective method of birth control (failure rate less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Out-of-hospital Cardiac Arrest Age ≥ 18 years old Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause Return of spontaneous circulation (ROSC) Unconsciousness (Glasgow Coma Score < 8) (patients not able to obey verbal commands)after sustained ROSC In-hospital cardiac arrest OHCA of presumed non-cardiac cause, e.g. after trauma or dissection/rupture of major artery OR Cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging) Known bleeding diathesis (medically induced coagulopathy (e.g warfarin, clopidogrel) does not the patient) Suspected or confirmed acute intracranial bleeding Suspected or confirmed acute stroke Unwitnessed asystole Known limitations in therapy and Do Not Resuscitate-order Known disease making 180 days survival unlikely Known pre-arrest CPC 3 or 4 Temperature < 30°C on admission | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Portopulmonary Hypertension Pulmonary Arterial Hypertension Pulmonary Hypertension Patients must: 1. Had portal hypertension. 2. Be otherwise suitable candidates for OLT. 3. Had severe pulmonary arterial hypertension (PAH) defined as a resting mean pulmonary arterial pressure (mPAP) >35 mmHg and pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) by right heart catheterization (RHC) performed as part of standard of care evaluation within 90 days of enrollment. 4. Treprostinil therapy must be recommended by the treating physician per standard of care. 5. Be NYHA Functional Class II, III, or IV. 6. Had pulmonary capillary wedge (PCW) pressure ≤18 mmHg and transpulmonary gradient (TPG) ≥15 mmHg Patients must not: 1. Had received any any investigational therapy as part of a clinical trial for any indication within 30 days prior to enrollment. 2. Had a change in dose of treatment for PAH (bosentan [Tracleer], ambrisentan [Letairis], tadalafil [Adcirca], or sildenafil [Revatio]), within 30 days prior to enrollment. That is, subjects may have been treated with any of these agents provided the dose was stable for at least 30 days prior to enrollment. 3. Had renal failure requiring hemodialysis | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-85.0, Anemia COPD t part of the study COPD clinically stable (patients with post-bronchodilation FEV1/FVC <0.7 and no acute exacerbations, hospital admissions or treatment changes in the last 3 months) d and 3rd part As above t part of the study history of asthma history of respiratory infection in the last 3 months d and 3rd part: As above and additionally history of malignancy or haematologic disorder acute or chronic inflammatory disease systematic or autoimmune disorder thyroid disease liver cirrhosis heart failure (ejection fraction <55%) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Treatment for PAH with sildenafil at a dose of 20mg tid or greater for at least 30 days Clinical decision to convert from sildenafil to tadalafil therapy Patient consents to study participation (for patients who have already transitioned from sildenafil to tadalafil therapy prior to study initiation or identification of the patient, if the patient has provided consent for use of their medical record for research, retrospective review of the transition process will be performed. When possible, these patients will be approached about prospective data collection for the study if the transition occurred less than 3 months prior to consideration of prospective study participation) Non-group I PAH Age less than 18 | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Nocturnal Desaturation Patients with a diagnosis of COPD supported by a history of past smoking and obstructive disease: FEV1<70% predicted, FEV1/FVC<70% and a total lung capacity by body plethysmography >80% predicted Stable COPD at study entry, as demonstrated by (1) no acute exacerbation and (2) no change in medications for at least 6 weeks before enrollment in the trial Non-smoking patients for at least 6 months before enrollment in the trial SpO2 at rest < 95% Patients fulfilling the current definition of nocturnal oxygen desaturation, i.e., >=30% of the recording time with transcutaneous arterial oxygen saturation <90% on at least one of two consecutive recordings Ability ot give informed consent Patients with severe hypoxemia fulfilling the usual for continuous oxygen therapy at study entry: PaO2 <=55 mmHg; or PaO2 <= 59 mmHg with clinical evidence of at least one of the following: (1) with right ventricular hypertrophy (P pulmonale on ECG:3 mm leads ll, lll, aVf); (2) right ventricular hypertrophy; (3)Peripheral edema (cor pulmonale); (4) hematocrit >=55% Patients with proven sleep apnea (defined by an apnea/hypopnea index of >=15 events/hour) or suspected sleep apnea on oximetry tracings Patients currently using nocturnal oxygen therapy Patients with known left heart or congenital heart diseases, interstitial lung diseases, bronchiectasis as the main cause of obstructive disease, lung carcinoma, severe obesity (body mass index >= 40 kg/m²), or any other disease that could influence survival | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 50.0-999.0, Heart Failure, Diastolic Age >50 years Recent AMI (within 21 days) defined according to ESC/ACC guidelines Doppler echocardiographic signs of elevated filling pressures defined as diastolic E/e' ratio >15, or diastolic E/e' ratio 8-15 and left atrial volume index>32 ml/m2 Preserved LV systolic function (EF>45%) Written informed consent Ongoing myocardial ischemia Ongoing treatment with nitrates Poor echocardiographic window Inability to exercise Permanent atrial fibrillation or paced rhythm Planned coronary artery bypass grafting Other noncardiac condition with expected survival less than 6 months Unwilling to participate Known intolerance to sildenafil Non-arteritic anterior ischaemic optic neuropathy | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 19.0-100.0, Cardiovascular Risk Factors Age ≥ 65 years 2. Hypertension (HTN) 3. Diabetes 4. Obesity (body mass index [BMI] >35) 5. Renal insufficiency 6. Tobacco usage 7. Hypercholesterolemia 8. Sleep apnea/heavy snoring at night 9. Clinical diagnosis of CHF as defined by: 1. Dyspnea on exertion 2. Paroxysmal nocturnal dyspnea 3. Orthopnea 4. Elevated jugular venous pressure 5. Pulmonary rales 6. Third heart sound 7. Cardiomegaly or pulmonary edema on chest x-ray 8. Peripheral edema 9. Hepatomegaly 10. Pleural effusion 10. Palpitations/irregular heart beats 11. Chest pain at rest and or exercise 12. Murmur on examination 13. Known coronary artery disease (CAD)/stents/coronary artery bypass graft (CABG) 14. Known valvular disease 15. Known stroke or transient ischemic attacks (TIA) Patients expected to say in the hospital for less than 24 hours. 2. Inability of undergo TEE and TTE 3. Clinical evidence or suspicion of elevated intracranial pressure. 4. Preoperative shock or systemic sepsis 5. Emergency Operation 6. ASA Class V 7. Inability of give informed consent 8. Participation in another clinical trial 9. Prisoner | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 20.0-80.0, Pulmonary Arterial Hypertension The patients aged from 20 to 80 years 2. Newly diagnosed WHO category I PAH patients: Patients who meet the following within 3 months obtained by right heart catheterization (mean PAP of more than 25 mm Hg at rest and mean pulmonary arterial wedge pressure (PCWP) or left ventricular end-diastolic pressure of 15 mm Hg or less) or echocardiography (peak PAP of more than 40mmHg and mean PAP more than 30mmHg). 3. Previously diagnosed PAH patients who refractory to conventional treatment except iloprost inhalation solution (Ventavis): Patients meet the echo (peak PAP of more than 40mmHg and mean PAP more than 30mmHg) who have been treated with PAH medications except iloprost inhalation solution (Ventavis) after diagnosed as WHO Group 1 PAH based on prior RHC data (above criteria) but refractory to them. 4. The patients who are able to undergo low intensity exercise test (low dose bicycle or walking) The patients with other left heart disease (category II in WHO classification of pulmonary hypertension); ex. Congestive HF, cardiomyopathy, significant valvular heart disease, significant arrhythmia, suspicious elevated PCWP. 2. The patients with category III,IV and V in WHO classification of pulmonary hypertension Pulmonary hypertension with lung disease and/or hypoxemia Chronic obstructive pulmonary disease Interstitial lung disease Sleep disorder breathing Alveolar hyperventilation disorders Chronic exposure to high altitude Developmental abnormalities Pulmonary hypertension due to chronic thrombotic and/or embolic disease Thromboembolic obstruction of the proximal pulmonary arteries | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-80.0, COPD Pulmonary Hypertension COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator Age 40-80 years Pulmonary hypertension Consent to participate in the study Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics Recent exacerbation (<4 weeks) (temporally) Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir) Ischemic optic neuropathy Patients treated with phosphodiesterase-5 inhibitors Patients with ischemic cardiopathy Systemic disease that could modified the results Patients unable to practise exercise | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-90.0, Hypertension Diagnosis (new or established) hypertension, defined by serial measurements >/= 140/90 Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler Severe bronchospastic disease/ reactive airway disease Inability to tolerate beta blocker therapy including: >1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia Subjects with physical limitations that would prevent them from participating in an exercise treadmill test Age <18 or >90 years Those with life expectancy <1 year Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms Chronic Kidney Disease 3 or greater (CrCl <30 cc/min) Subjects with active ischemia or evidence of ischemia on initial stress echocardiography | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Atrial Septal Defect Patent Foramen Ovale Allergic Reaction to Nickel Patients ≥ 18 years Secundum atrial septal defect (ASD) ≤ 1 cm on transesophageal echocardiography or patent foramen ovale (PFO), without contraindications to antiplatelet and/or antithrombotic therapy, and Suitable anatomy for device closure with one of the following: Amplatzer atrial septal occluder, Amplatzer Cribriform septal occluder, Amplatzer PFO occluder, or the Gore Helex septal occluder | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 3.0-60.0, Thrombosis Age≥3 years Diameter of defect≥5mm and increasing volume load of right heart ≤36 mm secondary left to right shunt The distance between defective edge and coronaria venosus sinus, inferior caval vein, superior vena and pulmonary vein≥ 5 mm, between artrial-ventricular valve≥7 mm The diameter of defect>Occluder No other cardiac anomalies need surgery intervention Hypertension Coronary artery disease Diabetes Atrial fibrillation and oral contraceptive medication Aspro, clopidogrel and warfarin in 2 weeks | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, PAH from Imatinib Trial Male or Female 18 years or older A current diagnosis or Pulmonary Arterial Hypertension according to the Dana Point 2008 Meeting: WHO Diagnostic Group I, idiopathic or heritable (familial or sporadic) PAH, PAH associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. PAH following one year repair of congenital heart defect (ASD, VSD, or PDA), or PAH associated with diet therapies or other drugs A PVR>1000dynes.sec.cm-5(as assess by RHC at screening or in the 2 months preceding the screening visit despite treatment with two or more specific PAH therapies, including endothelin receptor antagonists (ERA), phosphodiesterase 5 inhibitors (PDE5), or inhaled, intravenous or oral prostacyclin analogues for ≥3 months. On stable background therapy doses for ≥ 30 days except for warfarin (≥30 days but doses can vary even within the mouth before enrollment) WHO Functional Class II-IV. For WHO Functional Class IV, one of the 2 or more specific PAH therapies must be an inhaled, intravenous or oral prostacyclin analogue, unless the subject has been shown to be intolerant of prostacyclin analogues WD≥150meters and ≥450meters at screening. Distances of two consecutive 6MWTs should be within 15% of one another Ability to provide written informed consent from Imatinib Trial Women of childbearing potential who are not practicing birth control methods Pregnant or nursing (lactating) women, where pregnancy is defined as the state of positive hCG laboratory test (> 5 mIU/MI) Have previously received treatment with imatinib In treatment with chronic nitric oxide therapy Pre-existing lung disease including parasitic diseases affecting lungs, congenital abnormalities of the lungs, thorax or diaphragm or bronchial asthma associated with chronic hypoxia that may contribute to severity of PAH With a pulmonary capillary wedge pressure >15 mm Hg to rule out PAH secondary to left ventricular dysfunction With a diagnosis of pulmonary artery or vein stenosis With other diagnosis of PAH in WHO Diagnostic Group 1 re excluded including congenital systemic to pulmonary shunts (large, small that not surgically repaired, portal hypertension, HIV infection, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopthaies, myeloproliferative disorders) With a diagnosis of PAH associated with: venous hypertension (WHO Diagnostic Group II), hypoxia (WHO Diagnostic Group III), chronic pulmonary thromboembolic disease (WHO Diagnostic Group IV) or other miscellaneous causes (WHO Diagnostic Class V, which includes sarcoidosis, histiocytosis X, lympangiomatosis, compression of pulmonary vessels) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 25.0-90.0, Chronic Obstructive Pulmonary Disease Patient with COPD and increased SPAP >55 on echocardiogram will be screened for the study. 2. Patients with normal wedge pressure ( [PCWP] ≤ 15 mm Hg), mean PAP ≥ 35 mm Hg and a pulmonary vascular resistance (PVR 0 wood unit)on right heart catheterization. 3. Diagnosis of COPD according to GOLD guidelines 4. The patient can read, understand and sign the informed consent Other identified cause for pulmonary hypertension | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure Have ischemic or non-ischemic cardiomyopathy with either a history of reduced or preserved ejection fraction and heart failure for at least 6 months NYHA Class III documented at screening visit Be receiving appropriate medical therapy for heart failure as per ACC/AHA guidelines (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) and beta-blocker) for at least 3 months prior to the randomization visit. Subject has been on stable medications maximized to the subject's tolerance of ACE or ARB and beta-blockers as determined by the study investigator for at least 30 days prior to randomization. Stable is defined as no more than a 100% increase or 50% decrease in dose. These may be waved if a subject is intolerant of ACE, ARB or beta-blockers, or these agents are not indicated under the Guidelines. Such intolerance or lack of indications must be documented Have a minimum of one (1) prior hospital admission within the last 12 months for acute exacerbation of HF of at least one (1) calendar date change duration requiring intravenous or invasive HF therapy. If CRT device previously implanted, the heart failure hospitalization must be ≥ 30 days after CRT implantation. Alternatively, if patients have not had a heart failure hospitalization within the prior 12 months, they must have an elevated Brain Natriuretic Peptide (BNP) level of at least 400pg/ml or an N-terminal pro-BNP (NT-proBNP) level of at least 1,500pg/ml, according to local measurement at the time of screening (within 30 days of the screening visit/consent) Provide informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits Are able to schedule Therapy Initiation within two weeks. Enrollment/Randomization may be delayed until this criterion is met Are under the age of 18 years Are pregnant Have intractable HF with resting symptoms despite maximal medical therapy (persistent NYHA Class IV and ACC/AHA HF Stage D). This includes patients receiving continuous or intermittent outpatient intravenous vasoactive medications (e.g., IV inotropes, IV vasodilators), patients treated with a ventricular assist device (VAD), and patients who have received a cardiac transplant or are listed for cardiac transplantation and likely to be transplanted within 12 months even if their functional status has improved to NYHA Class III. Patients listed for cardiac transplantation who are not likely to be transplanted within 12 months and who have improved to NYHA Class III without outpatient IV vasoactive medications or a VAD are eligible for the study, if they meet the other inclusion/ Have a resting systolic blood pressure < 80 or > 180 mmHg Have an acute MI, Acute Coronary Syndrome, Percutaneous Coronary Intervention (PCI), new cardiac rhythm management device (Pacemaker, ICD, and CRT), CRM system revision, lead extraction or cardiac or other major surgery within 40 days Have known coexisting, untreated, hemodynamically severe stenotic valve lesions, vegetations, hypertrophic cardiomyopathy with significant resting or provoked subaortic gradient, acute myocarditis, tamponade, or large pericardial effusion Have an Atrial Septal Defect or Patent Foramen Ovale (with more than trace shunting on color Doppler or intravenous bubble study) or surgical correction of significant congenital heart disease involving atrial septum such as PFO or ASD closure device Have a Stroke or Transient Ischemic Attack within 6 months Have inadequate vascular access for device implantation | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Chronic Heart Failure Male or female ≥18 years; 2. Chronic heart failure NYHA class III-IV of ischemic and non-ischemic etiology; 3. Screening Left ventricular Ejection Fraction (LVEF) ≤ 30% measured at baseline by echocardiography; 4. Screening 6 minute walk test score of less than 450 meters measured at baseline; 5. Hospitalization for heart failure or outpatient IV administration of inotropic agents, human B-natriuretic peptide or IV diuretics within the past 12 months (stable for at least 2 weeks); 6. On standard optimal medical therapy for CHF before medical therapy.* 7. No changes in active cardiac medications during the 1 week prior to treatment; 8. Written informed consent Patients with current or prior symptoms of heart failure and reduced LVEF should be on stable optimally uptitrated medical therapy recommended according to current guidelines (Circulation. 2005; 112 (12): e154) as standard of care for heart failure therapy in the United States. This minimally includes an ACE-inhibitor (ACE-I) at stable doses for 1 month prior to enrollment, if tolerated, and a beta blocker (carvedilol, metoprolol succinate, or bisoprolol) for 3 months prior to enrollment, if tolerated, with a stable up-titrated dose for 1 month prior to enrollment. This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 1 month prior to enrollment, if tolerated, when ACE-I is not tolerated. Stable is defined as no more than a 100% increase or a 50% decrease in dose. If the patient is intolerant to ACE-I, ARB, or beta blockers, documented evidence must be available. In those intolerant to both ACE-I and ARB, combination therapy with hydralazine and oral nitrate should be considered. Therapeutic equivalence for ACE-I substitutions is allowed within the enrollment stability timelines. Aldosterone inhibitor therapy should be added when NYHA Class III or IV symptoms occur on standard therapy. If aldosterone inhibitor therapy is administered in Class II patients, it must be initiated and optimized prior to enrollment. Eplerenone requires dosage stability for 1 month prior to enrollment. Diuretics may be used as necessary to keep the patient euvolemic. 1. Inability to comply with the conditions of the protocol; 2. Inability to perform cardiopulmonary exercise test due to mechanical physical limitations 3. Presence of a transplanted tissue or organ or LVAD (or the expectation of the same within the next 12 months); 4. Planned AICD or CRT within the next 12 months unless AICD is prescribed for primary prevention 5. Pacemaker dependent patients. 6. Acute MI, CABG, PTCA, within the past 3 months 7. Chronic refractory angina or peripheral vascular pain; 8. Valvular heart disease requiring repair or replacement; 9. Need for chronic intermittent inotropic therapy; 10. Malignancy: evidence of disease within the previous 5 years; 11. Known HIV infection or immunodeficiency state; 12. Chronic active viral infection (such as hepatitis B or C); 13. Severe systemic infection: defined as patients undergoing treatment with antibiotics; 14. Active myocarditis or early postpartum cardiomyopathy (within the first 6-months of delivery); 15. Systemic corticosteroids, cytostatics and immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs taken within 4 weeks prior to study treatment; 16. Patient is pregnant, of childbearing potential and not using adequate contraceptive methods, or nursing.; 17. Patient scheduled for hospice care; 18. Any other medical, social or geographical factor, which would make it unlikely that the patient will comply with study procedures (eg. Alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location and a history of non-compliance) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 19.0-90.0, Hypertrophy, Left Ventricular Aortic Stenosis Myocardial Ischemia Cardiopulmonary Bypass severe aortic stenosis left ventricular hypertrophy of more than 10mm IVS thickness normal ejection fraction moderately or severely reduced systolic left ventricular function (ejection fraction <30%) atrial fibrillation or flutter intolerance to glutamate | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 25.0-50.0, Erectile Dysfunction exclusive diagnosis of psychogenic ED, using a checklist for DSM-IV criteria.Morning erections, situational erections (masturbatory or with another partner), or acute onset are characteristics of psychogenic ED; 2. age between 25 and 50 years; 3. mild and moderate erectile dysfunction according to the International Index of Erectile Function (IIEF); 4. stable heterosexual relationship for at least 1 year, and in accordance with during short-time psychotherapy focused on sexuality; (f) informed consent from the patient Patients were excluded if presenting significant clinical diseases, major depressive disorder or other severe mental disorder, primary no erectile sexual disorder (e.g., hypoactive sexual disorder), penile anatomic defects; users of medications that could interfere with sexual function; patients with any kind of physical limitations for the use of sildenafil citrate (current use of nitrates, past history of retinitis pigmentosa, allergies); and significant drug, alcohol or tobacco use | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Pulmonary Hypertension Diastolic Heart Failure LVEF >50% sinus rhythm and stable clinical condition defined as no changes in therapeutic regimen, or hospitalization in the 6 months preceding recruitment pulmonary artery systolic pressure > 40 mm Hg Patients receiving nitrates A history of pulmonary disease Alternative causes of PH other than cardiac-related Renal failure (creatinine > 2mg/dL) Anemia Pericardial disease Cardiac amyloidosis | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 12.0-999.0, Respiration, Artificial Respiratory Distress Syndrome, Adult Acute onset shortness of breath(<7 days) PaO2/FiO2 < 200 mm Hg (regardless of PEEP) Bilateral infiltrates on frontal chest radiograph <18 mm Hg when measured or no clinical evidence of left atrial hypertension Age less than 12 years Patients having underlying chronic lung disease Contraindication to permissive hypercapnia (raised intracranial pressure, acute cerebrovascular disorders, acute or chronic myocardial ischemia, right ventricular failure, uncorrected severe metabolic acidosis, sickle cell anemia, tricyclic antidepressant overdose, pregnancy) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Mitral Valve Insufficiency Atrial Fibrillation Heart Failure Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study Presence of mitral stenosis More than mild severity of aortic valvular problem Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) Rhythm other than sinus rhythm Inadequate image quality Lack of informed consent | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-75.0, Pulmonary Hypertension to 75 years of age at Visit 1 Male and female subjects with symptomatic PAH (Group I Dana Point Updated Clinical Classification 2008), a 6-min walking distance (6MWD) of more than 150 m, a pulmonary vascular resistance (PVR) >300 dyn*s*cm-5, and a mean pulmonary artery pressure (PAPmean) ≥ 25 mmHg For Study Part 1: subjects on stable pretreatment with sildenafil at a dose of 20 mg tid Unspecific treatments which may also be used for the treatment of PAH such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. However, treatment with anticoagulants (if indicated) must have been started at least 30 days before Visit 1 and treatment with diuretics needs to be stable for at least 30 days before Visit 1 Subjects with supplemental long-term oxygen therapy may be included, if the amount of supplemental oxygen and the delivery method was stable on average for at least 90 days before Visit 1 SBP >/=95 mmHg and heart rate (HR) </=105 beats per minute (BPM) in the first 2 h after intake of sildenafil (measured at Visits 0 and 1) Women without child-bearing potential Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period Subjects must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures Subject's participating in another clinical trial or who have done so within 30 days before Visit 1 Previous assignment to treatment during this study Pregnant women Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator Subjects with substance abuse (eg alcohol or drug abuse) within the previous 180 days before Visit 1 Subjects with underlying medical disorders with an anticipated life expectancy below 2 years (eg active cancer disease with localized and/or metastasized tumor mass) Subjects with a history of severe allergies or multiple drug allergies Subjects with hypersensitivity to the investigational drug or any of the excipients Subjects unable to perform a valid 6MWD test, eg subjects with a severe peripheral artery occlusive disease Subjects with a relative difference (ie absolute difference/mean) of more than 15% between the | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure, Diastolic Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study Suspected acute ST elevation myocardial infarction Acute coronary syndrome with active ongoing chest pain Known or suspected acute aortic dissection Known or suspected cardiac tamponade Known history of unoperated constrictive pericarditis Known or suspected severe aortic stenosis or severe mitral regurgitation Heart rhythm other than sinus rhythm on pre-cath EKG Age < 18 years old Unable to provide informed consent | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Coronary Heart Disease Heart Failure HIV AIDS Metabolic Syndrome Age > 18 years Known HIV-infection Written informed consent Acute cardiovascular disease Unstable hemodynamic status in the three weeks before Pregnancy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 41.0-999.0, Dyspnea Able and willing to provide Informed Consent; ->40 years of age Estimated Body Mass Index >19 Patient presented to the emergency department with a chief complaint of acute dyspnea Patients with obvious trauma or acute anxiety as a cause of dyspnea Patient has already received directed therapy in the ED and symptoms are remarkably improved Physician concern regarding possible harm to patient caused by positioning or ambulating the patient for VRI testing Intubated or mechanically ventilated Acute hemodynamic or ventilator instability requiring immediate resuscitation Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture) Hirsutism | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Acute CHF Acute Stroke Syndromes Systemic Infections General years of age or older Able to provide informed consent No initiated therapy since arrival to the ED Must be enrolled within 4 hours of arrival to the ED for Acute CHF Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF Known history of physician diagnosed CHF Natriuretic peptide (BNP, MR-pro ANP, NT pro BNP) level will be ordered by the treating physician as part of the patient's work up for Acute Stroke Syndrome Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint General ESRD requiring hemo or peritoneal dialysis Suspected pregnancy Not able to be followed up in 30 days Patients with "comfort only" DNR status Patients with known STEMI Excessive agitation Transferred from another treating facility Known aortic valve disease On continuous IV home infusions (such as milrinone, primacor) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Septal Defects, Atrial Signed informed consent by patient prior to initiation of any study-mandated procedure Male or female patients > 40 years with atrial septal defect type secundum and > 40 years of age at the time of repair Women of childbearing potential must have a negative pre-treatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination Women not of childbearing potential are defined as postmenopausal (amenorrhea for at least 1 year), or documented surgically or naturally sterile Pregnancy or lactation Women of child-bearing age who are sexually active without practising reliable methods of contraception Any disease or impairment that, in the opinion of the investigator, excludes a subject from participation Substance abuse (alcohol, medicines, drugs) Other medical, psychological or social circumstances that would adversely affect a patient's ability to participate adequately in the study or increase the risk to the patient or others in the case of participation Insufficient compliance Subjects who are not able to perform cardiopulmonary exercise testing ASD repair < 6 months before PAH of any aetiology other than the one specified in the Impairment of organic function (renal, hepatic) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Severe Dyspnea CAPD AE COPD Acute Heart Failure Pulmonary Embolism tachypnea > 25 /min or Pa02 < 70 mmHg or SpO2 < 93% diagnosis suspected: CAP, PE,EACOPD, AHF other cause of dyspnea unreachable on Day 30 | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Adults With Congenitally Malformed Hearts adults with uncomplicated congenitally malformed hearts (ventricular septal defect, atrial septal defect, coarctation of the aortae, aortic valve stenosis) and complicated congenitally malformed hearts (tetralogy of Fallot, complete transposition of the great arteries, congenitally corrected transposition of the great arteries, Ebstein anomaly and Eisenmenger syndrome) complicating serious co-morbidity such as hereditary heart diseases (age-related coronary heart diseases, valve diseases), other diseases or life-threatening diseases, psychiatric illness or inability to read or understand Swedish | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure COPD Asthma criterion for the study was shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) were age <18 years, history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: pneumonia, pulmonary embolism, carcinoma, pneumothorax, pleural effusion, intoxications (drugs), anaphylactic reactions, upper airway obstruction, bronchial stenosis, and gastroesophageal reflux disorder | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Persistent Severe PH After Valve Therapy Proven pulmonary hypertension before valve replacement and informed consent for data acquisition patients do not meet | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Peritoneal Dialysis Pioglitazone Hypertriglyceridemia Insulin Resistance Inflammation All patients received more than one month regular continuous ambulatory peritoneal dialysis(CAPD) or intermittent peritoneal dialysis(IPD). The causes of chronic renal failure were diabetes and non-diabetes.- history of allergy to thiazolidinediones and fenofibrate; history of any sever adverse event for fibrate that can't be tolerated by the patients; patient can not be follow-up regularly; history of myocardial infarction(MI) or coronary artery bypass graft (CABG) surgery within the past 1 month, history of cerebral vascular accident (CVA) or percutaneous transluminal coronary angioplasty(PTCA) within the past 6 months; chronic use of non-steroidal anti-inflammatory drugs(NSAIDs), steroids or immunosuppressives; patient with the acute infection; patient with malignant tumor; have the evidence of severe hepatic injury (ALT/AST>100u/L).- | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 50.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) daily use of Chronic Obstructive Pulmonary Disease (COPD)-medication: (Global initiative for chronic Obstructive Lung Disease: GOLD stadia I-IV) years of age or older smoking history of at least 10 pack-years having asthma analphabetism | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-75.0, Chronic Obstructive Airway Disease Both men and women with age more than 18 years Known diagnosis of COPD (GOLD stage 2 or higher) Already using CPAP or BPAP device Estimated GFR <30 ml/min/1.73 m2 or on hemodialysis Women known to be pregnant or planning to be pregnant in next 6 months Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic Chronic atrial fibrillation or frequent premature ventricular contractions Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis Uncontrolled COPD or acute COPD exacerbation Known chronic inflammatory diseases like lupus or active infection | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-80.0, IPF A diagnosis of idiopathic pulmonary fibrosis that fulfills American Thoracic Society Consensus Criteria Unexplained worsening or development of dyspnea or hypoxemia within 30 days leading to the current hospitalization Radiographic imaging showing ground-glass abnormality and/or consolidation superimposed on a background of reticular or honeycomb pattern consistent with usual interstitial pneumonia Intent on the part of the treating physician to use high dose steroid therapy as a therapeutic effort to treat a diagnosis of acute IPF exacerbation Diagnosis of documented infection based upon clinical evaluation and microbial testing Diagnosis of thromboembolic disease by clinical assessment Diagnosis of an additional etiology for Acute Lung Injury/Acute Respiratory Distress Syndrome based upon clinical assessment to sepsis, aspiration, trauma, inhalational injury, acute pancreatitis, drug toxicity, blood product transfusion reaction, or stem cell transplantation Diagnosis of congestive heart failure that accounts for the hypoxemia Presence of active hepatitis B infection Coagulopathy defined as an International Normalized Ratio > 1.8, Partial Thromboplastin Time > 2 x control, and platelet count < 50,000 Hyperosmolar state or diabetic ketoacidosis to suggest uncontrolled diabetes mellitus or uncontrolled hypertension (systolic BP > 160 mm Hg and diastolic BP > 100 mm Hg) which would contraindicated the use of corticosteroids Hemodynamic instability defined as a vasopressor requirement which would contraindicate the use of plasmapheresis History of reaction to blood products, murine-derived products, or prior exposures to human-murine chimeric antibodies History of malignancy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 60.0-85.0, SECONDARY PULMONARY HYPERTENSION MITRAL STENOSIS CHILDHOOD RHEUMATOID FEVER CONGESTIVE HEART FAILURE Outpatient > 60 Yrs Old < 85 Yrs Old Stable disease Congestive heart failure NYHA IIIB/V Inoperable mitral stenosis due to childhood rheumatoid fever Mean pulmonary artery pressure > 40 cm H2O Prior treatment with endothelin receptor antagonist(s) Hospitalization (exacerbation) Cardiac valve surgery | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Hypertension years old and up have Pulmonary Hypertension (PH) Scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH unable or unwilling to give informed consent | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 65.0-999.0, Atrial Fibrillation Age ≥ 65 years at moment of screening, able to sign informed consent Documented paroxysmal AF in association with complaints in the last year, with at least 2 episodes of complaints attributed to AF in the previous 2 months Paroxysmal AF documented with at least one ECG with sinus rhythm not after cardioversion in the last year No prior use of amiodarone in the last 6 months and no usage longer than 4 weeks in total EF < 35 % or description of "poor left ventricular function" on echocardiogram. Measurement should not be older than 6 months at moment of screening Aortic, mitral, pulmonary or tricuspid valve regurgitation or stenosis, if graded severe (grade >3) Acute illness: unstable angina, infectious disease Primary structural or electrical heart disease: dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome, long QT syndrome Reversible causes (thyroid dysfunction, uncontrolled hypertension, ischemia) Previous ablation Contraindications for amiodarone; liver dysfunction (serum alanine aminotransferase >2.5 times upper limit); thyroid dysfunction; chronic lung disease; baseline QTc >460 ms. sinus node dysfunction (pause more than 3 seconds in sinus rhythm); second or third degree AV-block Contraindications for anti-coagulation: prior life threatening hemorrhage under use of Vitamin K antagonists Any myocardial infarction or PCI in previous 6 months CABG in previous 6 months | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 25.0-89.0, Pneumococcal Infection Able to understand and give informed consent. 2. Immunocompetent community dwelling subjects between the ages of ages of 25-40 and 60-89 years Prior vaccination with pneumococcal vaccine. 2. Receipt of any of the following products: 1. Blood products within 3 months prior to study entry or expected receipt at any time after study entry*. 2. Any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry*. 3. Any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry*. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, cerebrospinal fluid leaks, severe kidney disease, autoimmune diseases, severe gastrointestinal diseases and grade 4 hypertension per CTCAE criteria** Alcohol, drug abuse or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or known chronic infections including, but not limited, to known HIV, hepatitis B or C; organ transplant; immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids*** (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids**** or any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia and congenital immunodeficiency. 4. Conditions that could affect the safety of the volunteers such as: o Severe reactions to prior vaccinations. o An allergy to any component of the study vaccines (phenol, aluminum, CRM197 protein, succinic acid, Polysorbate 80) History of Guillain-Barré syndrome History of bleeding disorders. 5. Volunteers with any acute illness* including, but not limited to fever (> 100.4 F [> 38 C], regardless of the route) within 3 days prior to study entry. 6. Volunteers with social conditions or occupational conditions or any condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation. 7. Pregnant or breast feeding or women expected to conceive within 30 days after vaccination ***** An individual who initially is excluded from study participation based on one or more of the time-limited (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines ) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria Grade 4 hypertension per CTCAE is defined as Life threatening consequences(e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis) urgent intervention indicated. ***Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Chronic Heart Failure Advanced chronic heart failure (HF) will be defined as left ventricular ejection fraction less than 35%, creatinine less than 2 mg/dL, and CHF NY functional class III-IV for more than 3 months. Enrolled patients should be admitted to hospital due to heart failure requiring adjustment of inotropic agents or diuretics within recent 6 months presence of mitral stenosis or prosthetic mitral valve 2. any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) 3. inadequate image quality 4. lack of informed consent | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Chronic Congestive Heart Failure Patients suffering from CHF, NYHA II-IV class LV lower than 35% to LV lower than 45% Patients with additional disease with life-expectancy of less than 2 years | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-90.0, Acute Lung Injury Acute Respiratory Failure Hypoxemic and no hypercapnic acute respiratory failure severe dyspnea at rest with a respiratory rate >25 breaths/min PaO2/FiO2 <300 PaCO2 <45 mmHg age <18 years NPPV contraindications past history of respiratory chronic disease (COPD, cystic fibrosis…) cardiac pulmonary edema Pre-defined intubation other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12) profound aplasia (white cells count <1000/mm 3) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 8.0-18.0, Hypertension, Pulmonary Current diagnosis of PAH (WHO Group 1) with WHO class II or III symptoms in one of the following categories: Idiopathic, Heritable [familial], Secondary to connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease (CTD), systemic lupus erythematosus, or overlap syndrome), or Persistent PAH despite surgical repair (at least 6 months prior to the screening visit) of atrial septal defects, ventricular septal defects, atrio-ventricular septal defects, and persistent patent ductus Have met the following hemodynamic for subjects with right heart catheterization (RHC) when performed as part of the diagnosis or routine care: mean pulmonary arterial pressure (mPAP) of >/=25 mmHg, pulmonary vascular resistance (PVR) of >/=240 dyne sec/cm5, left ventricular end diastolic pressure (LEVDP) or pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg be treatment naïve, have discontinued treatment with another ERA (e.g., bosentan) at least 1 month previously because of elevated liver function tests (LFTs), or have been on a stable dose of drug therapy for PAH (e.g., sildenafil or prostacyclin) for at least one month prior to the Screening Visit Subjects who discontinued ERA treatment due to elevated LFTs, must have LFTs of <3 x Upper Limit of Normal (ULN) A female is eligible to participate in this study, as assessed by the investigator, if she is of: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b. Child-bearing potential has a negative pregnancy test and is not lactating at the Screening and Baseline/Randomisation Visits and, if sexually active, agrees to use 2 reliable methods of contraception from the Screening Visit until study completion and for at least 30 days following the last dose of study drug Subject or subject's legal guardian is able and willing to give written informed consent. As part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia currently taking an ERA currently taking cyclosporine A body weight is less than 20 Kg have not tolerated PAH therapy due to adverse effects which may be related to their mechanism of action (e.g., prostanoids, ERA, PDE-5 inhibitors) with the exception of liver abnormalities for those subjects who were receiving another ERA pregnant or breastfeeding diagnosis of active hepatitis (hepatitis B surface antigen and hepatitis C antibody), or clinically significant hepatic enzyme elevation (i.e., ALT, AST or AP >3xULN) at Screening severe renal impairment (creatinine clearance <30 mL/min) at Screening clinically significant fluid retention in the opinion of the investigator clinically significant anaemia in the opinion of the investigator a known hypersensitivity to the study drug, the metabolites, or formulation excipients | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-75.0, Heart Failure Systolic Heart Failure Acute Decompensated Heart Failure Adults (18 years of age and <75 years of age); AND 2. Admitted to the hospital or treated in an outpatient clinic with a diagnosis of decompensated HF for which treatment will be administered; i. BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during hospital admission or clinic visit. OR c. Seen in an outpatient setting (i.e. heart failure clinic, general practice or cardiology office, urgent care unit) with a documented history of HF and with signs of worsening HF condition or decompensation, where worsening HF condition is defined as one or more of the following; i. Increase in NYHA class with worsening symptoms (i.e. dyspnea, fatigue) at same level of activity ii. Symptoms requiring change in dosage of one or more of the following medications: 1. diuretic 2. beta blocker 3. ACE inhibitor iii. Physical evaluation consistent with worsening HF signs (i.e. elevated JVP, ankle edema, dyspnea, abdominal distension, >4 lb or >1.8 kg weight increase in past week) iv. HF admission in last 30 days with a documented BNP > 300 pg/mL (or NT-pro-BNP > 1500 pg/mL) during or since admission AND d. Presence of left ventricular systolic dysfunction (ejection fraction <40%); e. Successfully trained and deemed proficient on how to perform a fingerstick and to use the Test System. Each subject will undergo two proficiency assessments. i. The first assessment will be performed at the time in which the subject is found to meet the and deemed willing, able and reliable to complete the study tasks, and following initial training on the use of the test system. Successful completion of this first proficiency assessment will result in the enrolment of the subject into the study. The second assessment will be performed following one week (7 days ± 2 days) of home testing to demonstrate retention of the training. Successful completion of this second proficiency assessment will result in randomization of the subject into one of the three study arms of the study. Failure to demonstrate proficiency at this second assessment will result in the withdrawal of the subject from the study Unwilling or unable to provide written informed consent; 2. Acute coronary syndrome (ACS) that is a primary diagnosis; or secondary diagnosis that is concomitant with the primary diagnosis of decompensated HF and for which treatment will be provided. Note: A history of ACS is not cause for if it is not concomitant with the present decompensated HF for which admission is being made. Small elevations in cardiac troponin that are considered by the treating physician to be associated with myocardial injury due to the acute decompensated HF and not due to a concomitant ACS or myocardial infarction are not a basis for exclusion. 3. Previous cardiac transplantation or cardiac transplantation anticipated within 3 months; 4. Current or planned use of a left ventricular assist device (LVAD), use of outpatient intravenous inotropic HF therapy, major surgical procedure or percutaneous coronary intervention within 3 months; 5. Life expectancy less than 6 months due to causes other than HF or cardiovascular disease (e.g., cancer); 6. End stage renal disease (dialysis dependency); 7. Receiving any investigational medication; 8. Hematocrit outside the 25 to 50% range of the HeartCheck system; 9. Prisoner or other institutionalized or vulnerable individual; 10. Dementia, tremors or other impediments to performing daily home BNP testing via fingerstick (unless BNP testing will be conducted by qualified caregiver); 11. Deemed by the investigator not to be likely to comply with study-mandated procedures or instructions; 12. Residence in regions where either transmission of test system data or home visits are not possible | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure With Preserved Ejection Fraction Pulmonary Disease Left Ventricular Hypertrophy/Hypertension Male or female; Age 18 or older Left ventricular ejection fraction ≥ 50% Symptomatic heart failure or appropriate comparator group Informed consent signed by the subject Symptoms of active ischemia Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency Serum creatinine > 3.0 or chronic hemodialysis Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 3.0 times the upper limit of normal as read at the local lab Severe renal dysfunction, i.e. glomerular filtration rate (GFR) <30 ml/min Atrial fibrillation Myocardial infarction within the last year Coronary bypass surgery within the last 6 months Stroke within the last 6 months Known aortic aneurysm | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Lung Disease, Chronic Obstructive Lung Disease, Interstitial Asthma Sarcoidosis Hypertension, Pulmonary Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below Patients with CHF Patients with pulmonary hypertension with documented right heart catheterization data Patients with COPD in two subgroups Emphysema, (evidence of emphysema on High Resolution Computed Tomography, (HRCT) and airflow limitation of GOLD II severity who have had Carbon Monoxide Diffusing capacity, (DLCO) and Residual Volume(RV) measured, or patients without HRCT with measurements of lung volumes and diffusing capacity with Total Lung Capacity (TLC) ≥1.0 predicted, RV/TLC ≥0.4, DLCO ≤ 0.7 predicted Chronic Bronchitis (No evidence of Emphysema on HRCT and/or no evidence of air-trapping or reduced DLCO.) Patients with asthma according to ATS/ERS definition Patients with interstitial lung disease (ILD) of any etiology including sarcoidosis diagnosed by HRCT in sub groups as follows Mild ILD (TLC 0.71-0.79 predicted, DLCO ≥ 0.71 predicted) Moderate and severe ILD (TLC ≤ 0.7 predicted, DLCO ≤ 0.7 predicted) Patients unable to cooperate Inability to assume a semi-reclining or supine position Patients with severe chest wall deformity | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Patients must be at least 18 years of age at study index Patients must have a diagnosis of PAH. PAH is conventionally defined as a mean pulmonary arterial pressure (PAP) of > 25 mmHg and a pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) ≥ 240 dynes/s/cm-5 at right heart catheterization Patients must have initiated sildenafil for the treatment of their PAH; at dose ≥ 20 mg tid within 5 years prior to study initiation Patient has known contraindications to sildenafil at study index Patient participated in an investigational study of sildenafil treatment for PAH during the period beginning 6 months prior to study index | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-18.0, Pulmonary Hypertension All pediatric patients with pulmonary hypertension defined as a mean pulmonary artery pressure ≥ 25mmHg undergoing diagnostic cardiac catheterization for clinical purposes are potential subjects. Subjects must have preserved left ventricular function (ejection fraction ≥ 40 %). Subjects must have parental consent for enrollment Any patient with left ventricular dysfunction (EF < 40%). 2. Any patient with known pulmonary veno-occlusive disease | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 16.0-999.0, Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Neuromuscular Disease Chronic Obstructive Pulmonary Disease Patients over the age of 16 years. 2. Patients with confirmed diagnosis of Duchenne Muscular dystrophy or Chronic Obstructive Pulmonary Disease or Obesity Hypoventilation Syndrome. 3. Patients with evidence of nocturnal hypoventilation with an arterial carbon dioxide partial pressure of >6.0 kPa in the morning. 4. Patients with evidence of hypercapnic respiratory failure with an arterial carbon dioxide partial pressure of >6.0 kPa during the day. 5. No prior domiciliary ventilation Patients with other co-morbidities e.g. cancer or cardiac failure. 2. Patients with muscular weakness but an unconfirmed diagnosis of Duchenne Muscular Dystrophy, Obesity Hypoventilation Syndrome or Chronic Obstructive Pulmonary Disease. 3. Patients who have had an acute illness within the last 4 weeks prior to starting assessment for ventilation. 4. Patients who have an abnormal bleeding tendency (INR or APTTr >1.4 or platelets <100). 5. Patients with a psychological, social or geographical situation that would impair compliance with the project | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Automated Communication Tools Complex Medical Patients Are admitted to UPMC Presbyterian General Medicine, Geriatrics, Cardiology, or Surgery inpatient services Are 18 years of age or older Are currently receiving 5 or more medications Have 2 or more comorbid conditions present, defined using the Elixhauser comorbidity system (Med Care 1998;36:8-27 and Med Care. 2005 Nov; 43(11): 1130-9 ). These comorbidities are: congestive heart failure, cardiac arrhythmias, valvular disease, pulmonary circulation disorders, peripheral vascular disorders, hypertension, paralysis, other neurologic disorders, chronic pulmonary disease, diabetes uncomplicated, diabetes complicated, hypothyroidism, renal failure, liver disease, peptic ulcer disease excluding bleeding, AIDS/HIV disease, lymphoma, metastatic cancer, solid tumor without metastasis, rheumatoid arthritis/collagen vascular diseases, coagulopathy, obesity, weight loss, fluid and electrolyte disorders, blood loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression Have a Primary Care Physician who has outpatient data included on EPIC electronic health record Are admitted to critical care units Are admitted from skilled nursing facilities Have dementia Were previously enrolled in the study Are organ transplant recipients | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-90.0, Pulmonary Hypertension diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation informed consent Myocardiac Infarct within the last 12 months Uncontrolled ventricular arrhythmia Uncontrolled bradycardic or tachycardic supraventricular arrhythmia relevant operations within the last 12 weeks change of the hemodynamic therapy within the last 6 weeks joint diseases or diseases of peripheral vessels and nerves which may make the results of the six minute walk test unreliable | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-72.0, Persistent Pulmonary Hypertension Respiratory Failure Signed informed consent from legally acceptable guardian PPHN or hypoxemic respiratory failure associated with Idiopathic PPHN Meconium aspiration syndrome Respiratory distress syndrome Sepsis Pneumonia Greater than or equal to 35 weeks gestation Age at enrollment less than 72 hours Moderate hypoxemic respiratory failure, with 12<OI<35 (oxygenation index, calculated as FiO2 * mean airway pressure * 100 / postductal PaO2) Prior or immediate need for iNO or ECMO Profound hypoxemia: qualifying PaO2 <30 mmHg, from a blood gas drawn within 30 minutes of starting study drug infusion Hypotension: Mean arterial pressure <35 mmHg Congenital heart disease, except patent ductus arteriosus, atrial septal defect <1cm, or muscular ventricular septal defect <2mm Congenital diaphragmatic hernia or lung hypoplasia syndromes, diagnosed on the basis of prolonged oligohydramnios Active seizures Apgar score of <3 at 5 minutes Bleeding diathesis Receipt of any other experimental drug or device Receipt of any prohibited concurrent medication | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-56.0, Pulmonary Hypertension Pulmonary Arterial Hypertension Be informed of the nature of the study and is able to understand and has provided written informed voluntary consent Be healthy males or females, of any race, at least 18 years of age or the legal age of consent (whichever is greater) and less than 56 years of age at the time of the first dose of study drug (or sildenafil) Have a body mass index (BMI) >=18.0 and <32.0 kg/m2 and weigh at least 50 kg Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, urinalysis, methemoglobin), and 12-lead ECG that, in the opinion of the Investigator, would affect subject safety Agree to comply with the study procedures and restrictions Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, ocular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease Clinically significant illness (including lower respiratory tract infection) or clinically significant surgery within 4 weeks before the administration of study drug (or sildenafil) Use of any commercially marketed mouthwash or oral rinse with agents other than tap water as well as tongue brushing or scraping from screening onwards through completion of study Currently a smoker or has a past history of smoking (of >10 pack years) History of bronchial asthma or sleep apnea Evidence of restrictive or obstructive lung disease (Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <70%, FEV1 <70% predicted, and/or FVC <70% predicted) Family history of primary PH History of pulmonary embolism Evidence of supine hypertension or hypotension (systolic BP >180 mmHg or <90 mmHg and/or diastolic BP> 100 mmHg or <50 mmHg) pre-dose [NOTE: BP measurements may be repeated twice, at least 10 minutes apart] Orthostatic hypotension defined as a drop in systolic BP by >=20 mmHg or diastolic BP of >=10 mmHg at screening or predose or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to the standing position | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive Age ≥ 18 years Known or newly diagnosed COPD or PAH Written informed consent Present long-term oxygen treatment is no criterion Age < 18 years Right-heart catheterization not reasonable Pregnancy, Lactation Life expectancy <12 months due to any diseases aside from COPD Any medical, psychological or other condition, which limits the patient's ability to provide informed consent No written informed consent provided Current participation in another clinical trial | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Subjects eligible for enrolment in the study must meet all of the following 1. Type of subject: Outpatients 2. Informed consent: Subjects must give their signed and dated written informed consent to participate. 3. Gender: Male or Female 4. Age: 40 years of age or older at a clinic visit 5. COPD diagnosis: Subjects with an established diagnosis of COPD in the past 6 months or before. 6. Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis. 2. Lung diseases: Subjects with current active respiratory disorders other than COPD, e.g. lung cancer, tuberculosis. 3. Non-compliance: Unable to complete questionnaires | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure Pulmonary Disease, Chronic Obstructive Inflammation Chronic heart failure patients with left ventricular systolic dysfunction (left ventricular ejection fraction < 40%) Outpatients New York Heart Association (NYHA) class I-IV years and older Informed consent Patients who do not meet the Patients who are not able to cooperate or undergo pulmonary function tests Other diseases that can lead to obstructive lung function: asthma, cystic fibrosis Malignancy with bad prognosis (survival < 6 months) Hospitalisation to the pulmonary department in the past 6 weeks, in this case patients will have the pulmonary function tests ≥ 6 weeks after discharge Patients who are already participating in another study within the cardiology department Additional for the first primary objective Disorders/diseases that can lead to pulmonary function impairment Pulmonary: lung surgery (lobectomy/pneumectomy), parenchymal neoplasms, interstitial lung disease, sarcoidosis, pneumoconioses, lung abscess, lobar pneumonia, post infectious scarring, atelectasis, radiation fibrosis | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Heart Failure, Diastolic Diagnosis of RHC confirmed WHO Group I PAH n=20 Idiopathic, primary or familial pulmonary arterial hypertension PAH associated with one of the following connective tissue diseases: PAH associated with exposure to drugs and toxins eg, anorexigens, L-tryptophan, toxic rapeseed oil Stable PAH for at least 3 months if on therapy This patient population is closed to enrollment. Target enrollment of 20 subjects has been met WHO Group II Pulmonary Hypertension n=20 Pulmonary capillary wedge pressure PWCP greater than 15 AND Transpulmonary Gradient TPG greater than12 WHO Group III PH n = 10 Has WHO functional class II through IV symptoms Had the diagnosis of PH confirmed by a cardiac catheterization Both WHO Group I PAH and WHO Group III PH WHO GROUP I PAH, II and III PH Age 18 and older Able to participate in right heart catheterization Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Age less than 18 years Baseline systemic hypotension, defined as MAP less than 50 mmHg Required intravenous inotropes within 30 days prior to study participation; Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure greater than160 mm Hg or sitting diastolic blood pressure greater than100 mm Hg at screening Has a history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C with evidence of recent infection and/or active virus replication defined as moderate to severe hepatic impairment Child-Pugh Class B-C Has chronic renal insufficiency as defined by serum creatinine greater than 2.5 mgdL at screening or requires dialytic support Has a hemoglobin concentration less than 9 gdL at Screening History of atrial septostomy within 6 months prior to Day 1 visit Repaired or unrepaired congenital heart disease CHD Pericardial constriction Confirmed diagnosis of restrictive or congestive cardiomyopathy; Left ventricular ejection fraction 40 percent by multiple gated acquisition scan MUGA, angiography or echocardiography Symptomatic coronary disease with demonstrable ischemia; Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study Has a psychiatric, addictive or other disorder that compromises the ability to give informed consent for participating in this study. This includes subjects with a recent history of abusing alcohol or illicit drugs 30 days prior to study screening Day 0and for the duration of the study Poorly controlled asthma defined by active wheezing and or cough with FEV1 less than 70 percent predicted, responsive to inhaled BD greater than 15 percent increase in FEV1 with BD Investigators, study staff or their immediate families Clinically significant intercurrent illness (including lower respiratory tract infection) or clinically significant surgery within 4 weeks before the administration of study drug Personal or family history of congenital or acquired methemoglobinemia Personal or family history of RBC CYP B5 reductase deficiency Known or suspected hypersensitivity or allergic reaction to sodium nitrite Personal history of glucose-6-phosphate dehydrogenase G6PD deficiency or any contraindication to receiving methylene blue If female, is pregnant or breast feeding, or has a positive pregnancy test result predose Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days or 5 half-lives of the drug, whichever is longer before the first dose of study drug Blood loss or blood donation greater than 550 mL within 90 days or plasma donation greater than 500 mL within 14 days before administration of study drug RHC less than 2 weeks from treatment visit unless clinically indicated | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Autism Spectrum Disorder parents to a child with ASD none | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Healthy Dyspnea Healthy Unstable heart or circulation disease Stroke Seizure disorder Severe migraine headaches Liver or kidney disease Adrenal gland problem (Pheochromocytoma) Nerve problems that may affect your breathing sensation Brain cancer Drug or alcohol problem Systemic lupus erythematosis (SLE) | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-80.0, Pulmonary Hypertension COPD Patient affected by stable COPD under optimal treatment, chronic oxygen therapy in patients with hypoxia, with PaO2 at rest ≥ 60 mmHg and PaCO2≤ 55 mmHg, aged between 18 and 80 years old Group 1: BPCO GOLD I-III (post bronchodilator FEV1 ≥ 30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 30 mmHg and PCP <15 mmHg Group 2: BPCO GOLD IV (post bronchodilator FEV1 <30%, FEV1/FVC ≤ 0,7 , TLC ≥ 70%) + PAPm ≥ 35 mmHg and PCP <15 mmHg Different types of pulmonary hypertension (chronic, thromboembolic pulmonary hypertension, pulmonary arterial hypertension etc.) Significant left cardiac disease (LVEF <45%, cardiomyopathy, valvulopathy, unstable coronaropathy) Treatment with nitrates in the last 10 days, or in need of other nitrate therapy for different diseases Treatment with other specific drugs for arterial pulmonary hypertension (less than 4 weeks) Significant systemic disease other than COPD Recent exacerbations of chronic bronchitis (< 4 weeks) Pregnancy or breastfeeding, or women without an adequate contraceptive method for the whole study duration History of anaphylaxis or allergic reactions to 5-phosphodiesterase inhibitors Cancers within the last 5 years with the exception of localized cancers of the skin or of the cervix Hepatic insufficiency or chronic renal failure or hemoglobinemia < 10 g/dL during the screening phase | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS) 2. Age more than 18 years 3. Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease 4. Willing to consent to participate in the trial 5. WHO functional class I,II, III WHO functional class IV 2. Patient participating in any other trial 3. Concomitant coronary artery disease 4. Nitrate intake 5. Liver dysfunction 6. Pregnancy and lactation - | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 50.0-999.0, Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure Key Age 50 years or greater Hospitalization due to worsening COPD and/or CHF Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 <50% Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction < 40% Expects to have direct contact with children at least once a month Key Participation in another clinical study involving the use of investigational product | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Bundle-Branch Block Heart Septal Defects, Ventricular Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby No chart to be found No EKG to be found Known bundle branch block prior to the surgery Other arrythmias Use of ventriculotomy Other disease than VSD Pacemaker or other metallic implants Pregnancy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Osteoarthritis, Hip Patients with indication for THA Patients who refuse to participate in this study Patients who live outside the city of Porto Alegre, due to difficulties for visits and the protocol monitoring Patients with femoral neck fracture, due to the impossibility of evaluation | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Age ≥ 18 years COPD GOLD class 3-4 Life expectance > 12 months • Patient unable to use the equipment provided (alone or assisted) | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-75.0, Diseases of Mitral Valve Aortic Valve Disorder Atrial Septal Defects Intracardiac Myxoma elective procedure open heart surgery aortic valve surgery mitral valve surgery atrial septal defect repair surgery intracardial myxoma removal surgery local anesthetic allergy sulphide allergy asthma pregnant women neurological disease (TIA excluded) congestive heart failure left ventricle ejection fracture under 0.3 liver failure diabetes mellitus with documented polyneuropathy chronic pain condition | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.167-999.0, Congenital Heart Disease Pulmonary Arterial Hypertension Potentially operable patients with congenital cardiac septal defects (bi-ventricular physiology) and PAH, must have at least three of the following severity age > 18 months; absence of congestive heart failure (pulmonary congestion); Down syndrome; bidirectional shunting across the septal defect; periods of systemic (peripheral) oxygen saturation < 90% Patients with complex cardiac anomalies for whom there are no possibilities of complete repair. Patients with uni-ventricular physiology | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 50.0-90.0, Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Cor Pulmonale diagnosis of COPD stage II, III or IV according to the GOLD guidelines signed the informed consent ischemic cardiopathy severe valvular disease atrial fibrillation left bundle branch block | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.5-999.0, Fontan Physiology Patients With PB or PLE Fontan Physiology Patients Without PB or PLE Fontan physiology patients with PB or PLE Fontan physiology patients without PB or PLE Glenn physiology patients ventricle patients with Atrial Septal Defect Patient has scheduled cardiac catheterization (of right and left heart) Age is greater than 6 months Weight is greater than 10kg Known Inflammatory Bowel Disease Hepatitis Congenital/ acquired liver disease Nephropathy Acute/ chronic renal dysfunction Active pulmonary hemorrhage Malignancy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Diastolic Heart Failure Hypertension Individual is diagnosed with heart failure with a normal LV ejection fraction. The diagnosis of HFNEF requires the following conditions to be satisfied signs or symptoms of heart failure normal or mildly abnormal systolic LV function (LVEF ≥ 50%) evidence of diastolic LV dysfunction Individual should fulfill the diagnostic WHO for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (< 140/90mmHg by 24 hour ambulatory BP measurement) Individual is adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months Individual is ≥ 18 years of age Known secondary cause of hypertension Anatomy not eligible for renal denervation Systolic heart failure (LVEF < 50%) Individual has an estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2, using the MDRD calculation Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, significant anaemia, or arrhythmias such as atrial fibrillation) Individual is pregnant, nursing or planning to be pregnant | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 6.0-999.0, Cystic Fibrosis Children ≥ 6 years and adults ≥ 18 years with CF in a stable state With a forced expiratory volume in one second (FEV1) ≤ 50% of predicted value Having a pulse oximetry (SpO2) in room air ≤ 90% for ≥ 10% of the night and/or a SpO2 ≤ 90% for ≥ 10 minutes during the night Any patient with prior noninvasive positive pressure ventilation (NPPV) but who has stopped NPPV at least 15 days before the start of the study Written approval by the patient and by the parents in case of a pediatric patient Patient having the French social security coverage Patients with a respiratory exacerbation during the last 15 days Patients with NPPV or long term oxygen therapy prior to the start of the study and unable to stop this treatment Impossibility of a medical examination Pregnant patient or breastfeeding patient | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension men and women over 18 years old carriers of a BMPR2 mutation without known PAH having given his informed consent men and women under 18 years old patients with a known PAH pregnant women adults protected detainees people in emergencies people refusing or unable to give informed consent no affiliation to a regime of social security | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive at least 40 years of age at index date continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period enrolled in fee-for-service plans without a diagnosis code of exclusionary comorbid conditions cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis) age less than 40 at index dates | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-85.0, Heart Failure Pulmonary Hypertension Men and women 2. 18 years of age. 3. Outpatients with chronic HF. NYHA class II-III on optimal treatment in sinus rhythm or atrial fibrillation 4. LVEF < 40% measured during the past 12 months 5. SPAP > 40mmHg using echocardiography 6. 6MWTD < 400 meters 7. NT-pro BNP > 400 pg/ml or BNP >100 pg/ml, measured during the past 12 months 8. Receiving optimal therapy, including diuretic, ACE-inhibitor, ARB, beta-blocker and aldosterone antagonist. Doses of all medication should be unchanged during the last 30 days before inclusion. 9. ICDs and CRTs (CRT-P, CRT-D) are permitted. Implantation should have been performed at > 3 months before to the trial Acute Coronary Syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months 2. Stroke within the last 3 months 3. Planned coronary angiography or planned device-implantation 4. Moderate to severe obstructive valve disease 5. Documented episodes of sustained ventricular tachycardia 6. Oral nitrate therapy or frequent use of sublingual nitrate 7. Concomitant disease which interfere with assessment of dyspnoea , severe COPD, asthma, restrictive lung disease, severe obesity 8. Anemia (hemoglobin < 10g/dL) 9. Uncontrolled hypertension ( SBP >160 mmHg and / or DBP > 90 mmHg) 10. Symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmHg 11. Clinically important renal dysfunction (GFR < 40m ml/min) 12. Women with child-bearing potential 13. Use of i) alpha-1 antagonist: doxazosin ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itraconazole, ketoconazole iii) CYP3A4-inducers: rifampicin iv) Any calcium channel blockers 14. Retinitis pigmentosa, previous diagnosis of NAION (non-arteritic ischemic optic-neuropathy), unexplained visual disturbance. 15. Sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, Peyronie's disease) that increases the risk of priapism. 16. Hepatic failure. 17. Drug and alcohol abuse which precludes compliance with the protocol. 18. Inability to understand or sign the written informed consent form of the study | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Hospital Readmission Post-discharge Care Transitions Congestive Heart Failure Chronic Obstructive Pulmonary Disease medical patients discharged to home or skilled nursing facility between October 1, 2011 and June 30, 2013 Cambridge Health Alliance PCP at time of discharge at least one of four risk factors for readmission: discharge diagnosis of CHF or COPD; length of stay >3 days; age >60; or previous hospitalization within the past 6 months | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 16.0-999.0, High Altitude Pulmonary Hypertension Sleep Apnea high altitude pulmonary hypertension confirmed by clinical presentation and systolic pulmonary artery pressure >50 mmHg measured by echocardiography at altitude of residence healthy subjects (high altitude controls) Both genders Age >16 y Kyrgyz ethnicity born, raised and currently living at >2500 m healthy subjects currently living at <1000 m (low altitude controls) Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography excessive erythrocytosis other coexistent disorders that may interfere with the cardio-respiratory system and sleep regular use of medication that affects control of breathing heavy smoking | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 20.0-65.0, Pulmonary Hypertension Mitral Regurgitation patients undergoing mitral valve surgery for chronic mitral regurgitation estimated pulmonary hypertension (systolic PAP > 50 mmHg estimated by the velocity of tricuspid valve regurgitation in preoperative transthoracic echocardiography) patients who agreed to participate in this study and signed written informed consent preoperative supraventricular tachycardia (SVT) atrial fibrillation atrial flutter multiple ventricular ectopic contractions continuous inotropic support LV ejection fraction (EF) < 30% emergent surgery obstructive cardiomyopathy bronchial asthma biochemical evidence of hepatic disease or renal impairment | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Mitral Regurgitation Mitral Valve Regurgitation Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects Heart Failure Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology. Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present. Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%) 2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Committee must also concur that the subject has been adequately treated. 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. 4. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group. 5. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%). 6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). 7. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant. 8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN). 9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator. 10. Age 18 years or older. 11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial. 12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent. 13. Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration. For the CPX Sub-study: Subjects have to meet the COAPT study to be registered in the CPX Sub-study. COAPT CAS study 1. Subjects must meet all of the above COAPT RCT and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS) Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use. 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration. 4. Percutaneous coronary intervention within 30 days prior to subject registration. 5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration. 6. Tricuspid valve disease requiring surgery or transcatheter intervention. 7. Aortic valve disease requiring surgery. 8. Cerebrovascular accident within 30 days prior to subject registration. 9. Severe symptomatic carotid stenosis (> 70% by ultrasound). 10. Carotid surgery or stenting within 30 days prior to subject registration. 11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure. 12. Presence of any of the following Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) Hemodynamic instability requiring inotropic support or mechanical heart assistance. 13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site. 14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration. 15. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration. 16. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes Insufficient mobile leaflet available for grasping with the MitraClip device Evidence of calcification in the grasping area Presence of a significant cleft in the grasping area Lack of both primary and secondary chordal support in the grasping area Leaflet mobility length < 1 cm 17. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. 19. Life expectancy < 12 months due to non-cardiac conditions. 20. Modified Rankin Scale ≥ 4 disability. 21. Status 1 heart transplant or prior orthotopic heart transplantation. 22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure. 23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated). 25. Active infections requiring current antibiotic therapy. 26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk. 27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically. 28. Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. 29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 30. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study. COAPT CAS study | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 55.0-90.0, Chronic Obstructive Pulmonary Disease Anxiety Depression Inpatients and specialist outpatients from: NUHS, SGH, CGH, SLH and AH Clinical diagnosis of chronic obstructive pulmonary disease (COPD) based on history, physical examination, spirometry, measurement of arterial blood gases, and chest radiographs, that meets the for COPD as defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD patients cases of all grades of severity, and co-morbidity, without restriction Participants provide written informed consent Known diagnosis of a psychiatric disorder that is under treatment Terminally ill COPD patients who are unable to complete baseline assessments | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Idiopathic Pulmonary Arterial Hypertension Primary Pulmonary Hypertension Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Adult participants Confirmed WHO class I pulmonary arterial hypertension Nitric Oxide Non-Responders on right heart catheterization Experience dyspnea, NYHA III-IV with poor oxygenation and quality of life despite standard treatments Must be able to swallow medications Pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e. left heart disease), 2) chronic hypoxemic states from lung diseases such as COPD, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4) sarcoidosis, 5) Lymphangiomyomatosis, 5) Pulmonary Langerhans Cell Histiocytosis Already on a calcium channel blocker Systolic blood pressure less than 90 Heart rate less than 55 Pregnant Cannot sign informed consent Right heart failure Pulmonary Veno-occlusive disease | 0 |
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