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A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Heart Failure EF <40%, getting majority care at the VA, not enrolled in another CHF study, ability to read English | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Heart Diseases Heart Failure Coronary Disease Diabetes Mellitus Hypertension Obesity | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Metastatic Cancer Newly diagnosed supratentorial solitary brain metastasis by enhanced MRI or CT scan Resectable disease Histological evidence of metastatic carcinoma by intraoperative pathology No primary lymphoma, germ cell carcinoma, or small cell lung cancer Age and over Performance status Karnofsky 70-100% Life expectancy At least 3 months | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 65.0-999.0, Brain Infarction Hypertension Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging Secondary hypertension Atrial fibrillation History or signs of cerebral disorders other than cerebrovascular disease Malignant tumor Chronic renal failure Severe congestive heart failure Hyperkalemia Stenosis of bilateral renal artery | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-79.0, Hypertension Ischemic Heart Disease Congestive Heart Failure Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure Pregnancy Severe renal damage Severe liver damage Acute myocardial infarction | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-79.0, Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke Clinical diagnosis of hypertension Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH) Patients who have already been administered ARB Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG) Severe/malignant/secondary hypertensive patients Pregnant women and women of childbearing potential History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block Severe renal impairment (Serum creatinine >3.0 mg/dl) Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure, Atrial Fibrillation Patient is willing and able to comply with the protocol Patient is willing to sign written informed consent Patient is expected to remain available for Follow-up visits Patient age is 18 years and older patient is on a stable medication regimen (including beta blockers) for at least 4 weeks prior to enrollment Baseline patients should meet all of the following to be determined at the baseline assessment procedure within 4 weeks prior to device implantation New York Heart Association functional classification III or IV QRS duration > 130 ms Left ventricular ejection fraction < 35% measured by echocardiography left ventricular end diastolic dimension > 55 mm measured by echocardiography Patients with unstable angina or who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within 3 months prior to enrollment or who are candidates for CABG or PTCA Patients who have experienced CVA or TIA with permanent disability within 3 months prior to enrollment Patient on, or anticipated to require, intravenous inotropic drug therapy Patients with severe primary pulmonary disease (such as cor pulmonale) Post heart transplant patients and patients on an urgency list for cardiac transplantation Supine systolic blood pressure greater than 170 mm Patient who are not expected to survive for 8 months of study participation due to other medical conditions Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control Serum creatinine greater than 250 mol/l Untreated hyperthyroidism | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure, Congestive Renal Insufficiency Stable congestive heart failure Impaired renal function Taking oral loop diuretic Acutely decompensated (unstable) and end stage heart failure Diuretics other than loop diuretics Pregnant or nursing Inability to follow instructions Participation in another clinical trial within past 30 days | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure, Congestive Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema Left ventricular ejection fraction less than 40% Indication of intravenous positive inotropic treatment Indication to withdraw beta-blocker treatment | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 65.0-999.0, Heart Failure, Congestive All new residents to participating long-term care facilities Age 65 or over Residing in any long-term care facility for more than 8 weeks Inability or refusal to obtain informed consent Palliative diagnosis and not expected to survive 6 weeks Residents admitted for respite care and expected to be returned to the community | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-18.0, Dilated Cardiomyopathy Pediatric Diagnosed with dilated cardiomyopathy normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker signed informed consent cannot travel back to Children's Healthcare of Atlanta for follow-up Patients with a transplanted heart no informed consent | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-80.0, Heart Failure, Congestive Congestive heart failure patients due to any cause Patients with normal cortical function Congestive heart failure patients who are on diuretic therapy Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention Patient refusal Signs of infection | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Symptomatic Decompensated Congestive Heart Failure Congestive Heart Failure in Acute Coronary Syndrome Patients with dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure) having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) >= 20 mm Hg in catheterized patients requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure NPatients having systolic blood pressure consistently less than 90 mm Hg having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of an intravenous agent with potent vasodilating properties having their most recent pulmonary capillary wedge pressure (PCWP) < 20 mm Hg within 24 hours before randomization having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome) | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 16.0-999.0, Leukemia Diagnosis of acute myeloid leukemia Previously untreated disease Previous hydroxyurea and/or corticosteroids are acceptable No preexisting history of a hematologic disorder Myelodysplastic features allowed No acute leukemia secondary to previous therapy No leukemic meningitis Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia) Creatinine < 2.0 mg/dL Pregnant or lactating patients are ineligible | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure Symptomatic heart failure and indication for cardiac resynchronization therapy (CRT), Hemodynamic stability with documented intolerance to beta-blocker therapy or treatment with beta-blocking agents at sub-optimal dosages (<25% of optimal dosage) chronic atrial fibrillation; indications for permanent antibradycardia pacing; mechanical tricuspid valve; Severe aortic stenosis or other primary valve disease causing cardiomyopathy | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Lung Cancer Patients must be enrolled in the trial: "A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) with Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy with OSI-774 for Stage III Non-Small Cell Lung Cancer," Principal Investigator: T. Mekhail, M.D Patient must be in maintenance therapy phase of the study and have received erlotinib for ≥ 1 week No known CNS primary or metastatic cancer at any time prior to time of enrollment No MRI evidence of pathological enhancement at the time of study entry Patients must use adequate birth control measures while in the study No significant side effects to erlotinib that require dose reduction or interruption None of the following medical issues which could make a lumbar puncture unsafe Platelets < 100,000/mm³ INR > 1.1 Known bleeding dyscrasia | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 30.0-999.0, Congestive Heart Failure (CHF) Physician diagnosed CHF Member of Kaiser Permanente Georgia | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-90.0, Congestive Heart Failure Patients will be recruited from the cardiology clinic at Hennepin County Medical Center. Patients are eligible for the study if they are Older than 18 Not pregnant Have heart failure with worsening hypervolemia despite oral diuretics Have at least two of the following signs or symptoms of hypervolemia: JVD, edema >1+, rales pulmonary edema on chest x-ray, orthopnea or PND Not more than 10 kg above their usual baseline weight Have, in the opinion of the treating physician, a need for a minimum of 2 liters of volume removal Systolic blood pressure < 90 mmHg Serum creatinine > 3.0 mg/dL Hematocrit >45 % Uncontrolled arrhythmias Need for hospitalization Require renal replacement therapy Contraindication to anticoagulation with heparin Poor venous access | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Heart Failure Hospitalized for episode of worsening heart failure as primary cause of admission or significant heart failure symptoms that develop during the hospitalization when the initial reason for admission was not heart failure Systolic dysfunction (LVEF < 40%) or heart failure symptoms in the setting of preserved systolic function (diastolic dysfunction) This study has no | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-999.0, Congestive Heart Failure Clinical diagnosis of heart failure based on a slight modification of the Framingham as previously described within 6 months before the entry Current status of heart failure is NYHA II or III Currently, loop diuretic(s) is (are) administered No change in baseline therapy and symptoms of heart failure within a month Current symptomatic hypotension Hypertension that has not been controlled to the satisfaction of the investigator Hemodynamically significant (in the investigators opinion) LV outflow tract obstruction (due to either aortic stenosis or ventricular hypertrophy) Acute coronary syndrome Primary pulmonary hypertension or pulmonary hypertension not due to LV dysfunction Serious cerebrovascular disease Acute myocardial infarction within the last 3 months Patients who require intravenous inotropes Cerebrovascular accident within the last 3 months Percutaneous coronary intervention or open heart surgery within the last 3 months | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-80.0, Hypertension African-American males and females current diagnosis of type 2 diabetes documented by medical history mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg HbA1C ≤ 9.5% having unilateral or bilateral renal artery stenosis having clinically significant cardiac dysrhythmias having a significant history of coronary artery disease within the past 6 months having a history or diagnosis of congestive heart failure (CHF) having any clinically relevant cardiac valvular disease | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Heart Failure, Congestive primary hospitalization with heart failure and LVEF < 40% patient informed consent has been obtained absence of pulmonary congestion age > 18 years End-stage renal or hepatic disease Acute myocardial infarction as primary diagnosis during index hospitalization Life-expectancy < 6-months Contraindication to beta blocker use Current beta-blocker therapy Planned bypass or valve surgery during index hospitalization | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 45.0-999.0, Congestive Heart Failure Age over 45 years old CHF class II or III with LVEF<40% Hospitalized at least once for CHF deterioration over previous 12 month period Able and willing to cooperate with this trial for at least a 3 month period Home close to participating center Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation Asthma or COPD | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Prostate Cancer Histologically confirmed adenocarcinoma of the prostate meeting any of the following for high-risk disease Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen [PSA]) Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA) Serum PSA ≥ 10 ng/dL (any grade or stage) Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram No clinical evidence of CNS metastases No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry Appropriate medical candidate for radical prostatectomy ECOG performance status 0-1 Creatinine ≤ 2.0 mg/dL | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-99.0, Congestive Heart Failure NYHA III-IV QRS > 120 msec On medical therapy, but beta blocker dose not @ target (carvedilol 25 bid, metoprolol succinate 200 qd) QRS < 120 msec On target beta blocker dose | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Diseases Advanced HF (Stage D or advanced Stage C HF) with symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function ("diastolic heart failure") Outpatient care setting (office, clinic or home hospice) Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + β-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered "advanced Heart Failure" but are not on recommended medications Can be awaiting LVAD, transplantation or other procedure Age > 18 years and able to sign informed consent to participate Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis Patient on hemodialysis or receiving mechanical ventilation Patients receiving investigational agents or devices Patients who have received heart transplant or a destination Left Ventricular Assist Device | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-999.0, Obstructive Sleep Apnea Syndrome Obstructive sleep apnea syndrome based on symptoms and a sleep study Sleep disorders other than obstructive sleep apnea syndrome Other than mild, stable cardiovascular disease Other than mild lung disease Chronic rhinitis, previous uvulopalatopharyngoplasty Treatment with drugs that affect respiratory center drive Internal, neurologic or psychiatric disease that interferes with sleep quality Previous intolerance to moderate or low altitude < 2600m | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Diabetes Mellitus Females of childbearing potential must be using appropriate birth during the entire duration of the study or must be surgically sterile Subjects with a clear diagnosis of type 2 diabetes mellitus using diagnostic of the American Diabetes Association who have been taking a sulfonylurea and/or insulin for at least 30 days prior to Visit 1 or who have been withdrawn from metformin therapy, during the 30 days prior to Visit 1, due to congestive heart failure Subjects with a clinical diagnosis of congestive heart failure, New York Heart Association Class II or early Class III. Subjects should not previously have been in Class IV heart failure Diagnosis of left ventricular congestive heart failure as evidenced by a left ventricular ejection fraction less than 40% at screening based on an echocardiogram Subjects who have demonstrated the need for oral hypoglycemic agents and have participated in dietary counseling Glycosylated hemoglobin greater than 7.0% at screening Subjects on optimal therapy for congestive heart failure. Medication doses should be stable for at least two weeks prior to randomization Naïve to antidiabetic therapy Within the past three months were treated with rosiglitazone, pioglitazone HCl, or troglitazone or those previously treated with rosiglitazone, pioglitazone HCl, or troglitazone but discontinued from therapy due to lack of efficacy or clinical or laboratory signs of intolerance Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis Has taken any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the timeframe of this study History of chronic alcoholism or drug abuse during the six months prior to the study Has had any of the following within three months prior to Visit 1: myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris, transient ischemic attacks, or documented cerebrovascular accident that in the investigator's opinion would warrant from the study Abdominal, thoracic, or vascular surgery during the three months prior to Visit 1 that in the investigator's opinion would warrant from the study Subjects with a planned surgical or catheterization intervention within the six months following Visit 1 Subjects awaiting cardiac transplantation Intercurrent illness severe enough to require hospitalization during the three weeks prior to Visit 1 | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-90.0, Heart Failure HF by Framingham At least one admission to hospital for HF within the last 180 days New York Heart Association Class II thru IV Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45% Creatinine clearance <40 mls/min/1.73m2 Potassium >5.0 mmol/L Recent acute coronary syndrome in the prior 4 weeks Planned revascularization, defibrillator or pacemaker in next 4 months Known previous intolerance to aldosterone antagonist | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure, Congestive Received or is eligible to receive a principal hospital discharge diagnosis of HF or decompensated HF is present as determined clinically by the patient care team Heart Failure is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this hospitalization episode | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure age18 or older primary diagnosis of CHF in the Emergency Department admission to the hospital or transfer to the Observation Unit minors, prisoners,pregnant women,unable to provide consent unstable angina or acute myocardial infarction in the ED dialysis dependent patients use of nesiritide as a therapy in the ED | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-80.0, Rheumatoid Arthritis Interstitial Pneumonia Diagnosis of RA according to the revised 1987 American Rheumatism Association Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening Worsening as demonstrated by any one of the following within the past year > 10% decrease in Forced Vital Capacity (FVC) increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion Diagnosis of UIP or NSIP by either of the following Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation History of clinically significant environmental or drug exposure known to cause pulmonary fibrosis Forced expiratory volume in one second (FEV1) FEV1/FVC ratio < 0.6 at screening (pre or post-bronchodilator) Residual volume > 120% predicted at Screening Evidence of active infection Any pulmonary condition other than UIP/NSIP, which, in the opinion of the site principal investigator, is likely to result in the death of the patient within the next year History of unstable or deteriorating cardiac or neurologic disease Pregnancy or lactation Treatment with cyclophosphamide, cyclosporine, interferon gamma or beta, anti-tumor necrosis factor therapy, anti-interleukin 1 (IL1) therapy or with endothelin receptor blockers within the last 8 weeks; experimental therapy for rheumatoid arthritis Creatinine > 1.5 X upper limit of normal range (ULN) at Screening | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Congestive Heart Failure Left ventricular ejection fraction </=35% as measured by nuclear imaging, echocardiography, or cardiac angiography within 6 months preceding enrollment. If the patient has had a myocardial infarction or heart surgery during this period, the ejection fraction must be remeasured Symptomatic CHF (NYHA class II-IV) at some time during the 6 months before randomization, despite therapy with an ACE inhibitor (however, patients who do not tolerate an ACE inhibitor are eligible). Asymptomatic patients (NYHA class I) with either a prior hospitalization for CHF during the 6 months before randomization or with a left ventricular ejection fraction of </=25% are also eligible History of significant AF, defined as either one episode lasting >/=6 hours (duration of AF will be determined by history), within the past 6 months with electrocardiographic confirmation; or an episode lasting >/=10 minutes (by history) within the past 6 months with electrocardiographic confirmation in a patient with a prior electrical cardioversion for AF In the opinion of the clinical investigator, the patient must be eligible for long-term treatment with either treatment strategy of AF AF is known to be present and uninterrupted for more than 12 months prior to randomization. However, if such a patient is cardioverted and maintained in sinus rhythm for >/=24 hours, he or she becomes eligible Reversible cause of AF such as acute pericarditis, pulmonary embolism, hyperthyroidism, alcohol intoxication AF occurring and not persisting beyond 10 days of surgery or myocardial infarction Reversible cause of CHF such as severe aortic or mitral stenosis and tachycardia-induced cardiomyopathy Decompensated CHF within 48 hours of randomization Antiarrhythmic drugs other than calcium channel blockers, beta-blockers or digoxin required for other arrhythmias or other indications More than 7 days of amiodarone therapy within the last month prior to randomization Second or third degree AV block, sinus pause >3 seconds, resting heart rate <50 bpm without a permanent pacemaker History of drug-induced Torsades de Pointes or congenital long QT syndrome Prior AV nodal ablation or Maze surgery | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 75.0-999.0, Heart Failure Acute exacerbation of chronic heart failure Age over 75 Appropriate care supervision at home Telephone connection Living in the hospital-at-home catchment area and informed consent Absence of family and social support Patients who need mechanical ventilation Severe dementia End-stage cancer History of severe renal impairment or hepatic failure with ascitis | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure diagnosis of NYHA I, II or III heart failure (as identified by any of the following physical findings of heart failure (jugular venous distension, crackles, edema, S3); pulmonary edema on chest x-ray; BNP > 100 pg/ml; or at least two of the following symptoms: paroxysmal nocturnal dyspnea, shortness of breath, swelling, fatigue previous chemotherapy that contributed to the development of heart failure (i.e., heart failure develops or worsens after receiving chemotherapy, with no other obvious explanation) oriented to person, place, and time living in the Houston area (Harris county or a contiguous county), or planning to stay in the area for at least the next 16 weeks 18 years of age or older diagnosis of cancer have completed treatment, or are on long-term adjuvant or maintenance chemotherapy only remain in NYHA class IV heart failure despite therapy have health problems or current treatments that would make exercise unsafe, as determined by the cardiologist cannot provide informed consent | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure Male or female aged 18 or above Congestive Heart Failure with symptoms for more than 4 weeks before starting study Provision of informed consent Current low blood pressure with symptoms Liver disease considered significant by the study doctor Pregnant or lactating females | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Right Sided Cardiac Failure Patients must have right sided failure secondary to right ventricular dysfunction, pulmonary hypertension, or tricuspid regurgitation Age greater than 18 years of age Right heart catheterization within the last year to rule out left-sided failure Evidence of fluid overload as indicated by 2 or more of the following: 1.) 2+ or more pitting edema of the lower extremities, 2.) scrotal or penile edema, 3.) JVP greater than or equal to 10 cm, 4.) abdominal ascites Pulmonary capillary wedge pressure above 16 mmHg or history of elevated left ventricular filling pressures Serum creatinine > 2.0 Current use of an angiotensin I converting enzyme inhibitor or angiotensin receptor blocker will preclude participation in the RAS neurohormone portion of the study | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Heart Failure chronic stable heart failure renal dysfunction or under treatment with antidiabetic agents | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-90.0, Heart Failure Male or female patient's > 21 years of age with a severe congestive heart failure (New York Heart Association class III or IV) requiring an immediate administration of intravenous vasodilators drugs, oxygen therapy, and no less than 160 mg of intravenous furosemide were eligible for inclusion Definite evidence of underlying heart failure was also required as shown by at least two of the following a) Orthopnea on admission b) X-ray showing evidences of elevated wedge pressure indicating congestive heart failure c) recent prior hospitalization (within the 30 days prior to the index hospitalization) because a congestive heart failure episode d) echocardiography data showing a poor left ventricular ejection fraction (0.40 or lower measuring with the biplane Simpson's method e) non-invasive ventilation to the maintenance of SaO2 above 90% f) wet rales in at least the lower half of the lungs fields Patients with a final diagnosis of Congestive Heart Failure as a consequence of necrotic or chronic ischemic heart disease, or infective origin such as chronic Chagas Disease, chronic valvular heart disease (surgically repaired or not), and idiopathic origin were also included for the present study Patients with a concomitant infective disease were excluded from the study Patients with evidence of evolving with multi organic failure (hepatic or renal dysfunction requiring dialysis), terminal disease, or any impeding cause of follow-up, including contraindications of vaccination, were excluded from the study Those with congestive heart failure following unstable coronary artery disease, or prior by-pass surgery, or angioplasty or congestive heart failure complicating myocardial infarction requiring urgent intervention were excluded also Those individuals who required mechanical ventilation on admission Patients with prior vaccinations were also excluded Pregnancy condition was an criterion Those patients who were unable or refused to give a written inform consent was also excluded of the present study | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 40.0-999.0, Hypertension Self-identifies as African American Resides in Washington, DC or surrounding communities Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists) Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke) Long-term kidney failure Any other life-threatening illness (e.g., advanced cancer) History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-65.0, Hyperglycemia Obese African American subjects (BMI equal or greater than 30) age 18-65 patients with a history of diabetic ketoacidosis as defined by the ADA patients admitted with hyperglycemia but without ketoacidosis (BG greater than 400ml/dl without evidence of ketosis/ketones obese nondiabetic controls (BMI >30; ruled out for diabetes with a 75g oral glucose tolerance test) patients with positive autoimmune markers [islet cell (ICA) or Glutamic acid decarboxylase (GAD) autoantibodies] patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism patients with bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies patients with fasting hyperglycemia (blood glucose > 120 mg/dl) after discontinuation of insulin therapy, and 6) pregnancy | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-95.0, Pulmonary Edema Patients in the intensive care unit using ventilator Asthma, COPD, non-ventilated patients | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure Patients with stable congestive heart failure on a prescription for diuretic drugs Acute heart failure Foreseeable need for further changes in medication Current medication containing vitamins Patients with a creatinine above 250 μmol/l | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 50.0-999.0, Congestive Heart Failure subjects will be at least 50 years of age women who are post-menopausal clinical evidence of congestive heart failure, with ongoing management by conventional medical therapy a left ventricular ejection fraction below 40% as measured by echocardiogram performed within 6 months of study enrollment Left ventricular end-diastolic dimension greater than 60 mm as measured by an echocardiogram performed within 6 months of study enrollment regular heart rate/pacer hemodynamically stable and able to complete symptom-limited bicycle ergometry exercise test and be in New York Heart Association Classification II or III Subjects with hematocrit equal to or less than 33% body mass index equal to or greater than 40 unstable angina within six months inducible ischemia by exercise stress testing, radionuclide scintigraphy, or dobutamine echocardiography known or suspected myocarditis known or suspected restrictive or infiltrative cardiomyopathy coronary artery stenosis >70% and < 100% by catheterization should such data be available inadequate cardiac echo window primary diastolic dysfunction in heart failure inability to perform cycle ergometry | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure Hypovitaminosis D Hypomagnesemia Hyperparathyroidism congestive heart failure pregnant hospitalized within one month taking calcium, vitamin D or magnesium supplements proteinuria > 1g/24h creatinine clearance <35 (MDRD) | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure Patients with documented heart failure (NYHA class II-IV) Use of both ACEi and ARB, ACEi and DRI, ARB and DRI treatment, or all three medications at Screening | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy Subject has severe heart failure (NYHA Class III or IV) Subject has experienced at least one heart failure event within six months prior to enrollment Subject continues to have heart failure symptoms despite receiving optimal medical therapy Schedule for implant of a CRT-D (Model 8770) Subject has signed and dated an informed consent form Any contraindication for standard cardiac pacing Any contraindication for ICD therapy Abdominal implantation site Hypertrophic or obstructive cardiomyopathy Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Recent (within the last month) or planned cardiac revascularization or coronary angioplasty Correctable valvular disease that is the primary cause of heart failure Mechanical tricuspid valve Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure Normal subject without history, signs-symptoms or diagnosis of heart failure Age over 18 and willing and able to provide informed consent Known allergy to electrode gel and medical adhesive used on electrocardiographic electrodes Pregnancy (as any effect of this device use on pregnancy is not known) Patient belonging to a vulnerable population such as institutionalized persons, prisoners and persons with decisional incapacity or dementia Presence of severe aortic regurgitation Second degree Mobitz type II or third degree heart block, unless treated with a cardiac pacemaker Implantation of a left ventricular assists device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (Cardiac Resynchronization Therapy) with the V-to-V interval set at more than 5 milliseconds offset Implantation of a cardiac resynchronization device within the last 30 days HEART Patients over the age of 18 and able to give consent Ability to understand and willing to sign informed consent | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-80.0, Sleep Apnea, Central Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive Pregnancy Myocardial infarction Unstable angina or cardiac surgery within the previous three months | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Hypertension currently taking an ACEi, ARB or both no change in these medications during the two weeks prior to study enrollment scheduled for non-cardiac surgery requiring regional or general anesthesia minimum overnight anticipated length of stay age ≥18 years explicit instructions provided to patient by surgical team regarding the perioperative management of ACEi or ARB significant hypertension in pre-operative assessment clinic (systolic blood pressure ≥180 mmHg OR diastolic blood pressure ≥110 mmHg) significant hypotension in pre-operative assessment clinic (systolic blood pressure < 90 mmHg) prior enrollment in the study participation in another research study of antihypertensive medications | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 60.0-999.0, Heart Failure Age greater than or equal to 60 years of age Symptoms of congestive heart failure Able to understand and give informed consent Age <60 years Does not have CHF Significant change in cardiac medication <3 weeks Myocardial infarction <3 weeks CABG surgery <3 months Angina pectoris not controlled during daily activity by pharmacological therapy or at <4 METS activity Sustained hypertension with systolic> 190 and diastolic> 110 on medications Valvular heart disease as the primary etiology of CHF Significant aortic stenosis Stroke of <3 months or with any physical restriction impairment that would prevent participation in exercise programs | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Decompensated Heart Failure >18 years old Severe systolic heart failure with ejection fraction <40% And Hospitalisation for decompensated heart failure And New York Heart Association (NYHA) III or IV And 1 of the following Jugular vein distension>6cm Tissue Doppler mitral annulus lateral>12 or medial>15 Chest X-ray: pulmonary edema or pleural effusion Need for inotropic or vasopressive agents Use of intravenous (IV) contrast media Acute coronary syndrome Need of dialysis Severe co-morbidity Contra-indications for anticoagulation Pregnancy | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-999.0, Heart Failure hospitalized with admitting diagnosis of heart failure in prior 8 weeks self-identified as African American community-dwelling (i.e., not in a long-term care facility) residence within a predefined radius in Baltimore City working telephone in their home provide signed informed consent cannot speak or understand English severe renal insufficiency requiring dialysis acute myocardial infarction within preceding 30 days receiving home care services for HF post discharge legally blind or have major hearing loss screen positive for cognitive impairment on the Mini-cog at baseline unable to stand independently on a weight scale (limited ability to participate in HAT system) weigh more than 325 pounds (exceed scale capacity) serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation) pregnant | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 65.0-999.0, Heart Failure Chronic Obstructive Pulmonary Disease patients aged 65 years and older must have a minimum of three chronic or vitality threatening diseases and/or use five or more medical drugs chronically in the last year must have dyspnea and/or reduced exercise tolerance (scored by two short questionnaires) patients with both confirmed COPD and heart failure (Spirometry performed < 1 year ago and heart failure confirmed by echocardiography) patients unable or unwilling to sign informed consent | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 19.0-999.0, Cesarean Section Pregnancy greater than 37 weeks gestation ASA (American Society of Anaesthesiologists) I and II classification of health. Class I a normal healthy patient and II a patient with mild systemic disease (i.e. mild asthma) Mothers presenting to the assessment unit with ruptured membranes or in the early stages of labour for whom a vaginal birth was not planned and who are therefore in need of urgent cesarean delivery Potential subjects need to be able to read and understand English, unless an independent translator is available Women having general anesthesia Mothers in active labour m or more dilated with regular coordinated contractions (3 in 10 minutes) ASA classification 3 or above Emergency cesarean delivery for fetal heart rate abnormalities Maternal age <19 BMI >40. Obesity makes it more difficult to site the combined spinal epidural which could lead to delay in positioning the patient quickly following subarachnoid block. Obesity can result in increased venal caval compression in the supine wedge position causing epidural venous plexus engorgement and dural sac compression which may result in a high block. A later study will look at the effects of positioning in the obese patient Mothers with a history of known tolerance to opioids Uterine over distension polyhydramnios, twin pregnancy and estimated fetal weight of over 4kg by ultrasound scan -Uterine over distension can result in increased aortocaval compression which may lead to engorgement of the epidural venous plexus and dural sac compression which may result in a high block | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Overweight Obesity BMI of at least 25.0 self-identifies as Black or African-American able to do mild physical activity such as walking or chair exercises has insulin dependent diabetes is pregnant, nursing, or had a baby in the past 4 months has ever been treated for an eating disorder (e.g. anorexia nervosa, bulimia) had a heart attack in the past 2 years requiring hospitalization has ever had a stroke has congestive heart failure has uncontrolled hypertension currently participating in another study is on a doctor-prescribed diet that cannot be changed (e.g. very low protein diet for a person in liver failure) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 70.0-999.0, Chronic Heart Failure Verified diagnosis of heart failure Left ventricle ejection fraction < 50 Stable medical treatment with Angiotensin Converting Enzyme blockers and Betareceptor blockers (if no contraindications) experience of fatigue according to the Multidimensional Fatigue Inventory years or older Swedish speaking Instable angina pectoris Myocardial infarction within the last three months Cognitive impairment No experienced fatigue | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | 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 any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) inadequate image quality lack of informed consent | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Cardiovascular Risk Factor African American adults > 18 years old | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-90.0, Bronchiectasis Bronchiolitis All patients with bronchiectasis or bronchiolitis All patients with severe lung disease other than bronchiectasis Active lung infection Active infection other site except the lung | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-999.0, Heart Failure, Congestive Subjects admitted to hospital with systolic heart failure(LVEF under 45%) in 2009 Subjects, age 20 or/and above Subjects admitted to hospital (emergency area, to internal medicine or to cardiology wards, CCU or intensive care) with dyspnea and verification of heart failure based on following criteria Symptoms typical of heart failure : breathlessness at rest or on exercise, fatigue, tiredness, ankle swelling and Signs typical of heart failure : tachycardia, tachypnoea, pulmonary rales, pleural effusion, raised jugular venous pressure, peripheral oedema, hepatomegaly Objective evidence of a structural or functional abnormality of the heart at rest : cardiomegaly, third heard sound, cardiac murmurs, abnormality on the echocardiogram, raised natriuretic peptide concentration Subject who expired during hospitalization | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Congestive Heart Failure (CHF) Clinical diagnosis of heart failure at levels III and IV, according to the classification of the NYHA (New York Heart Association) for 3 months or more Clinical diagnosis of LVEF less than 50% or were on diuretic therapy for more than three months with at least one previous hospitalization due to heart failure disease uncertain prognosis for 12 months due to other conditions acute coronary disease in recent months existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure) severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy) severe mental illness (active psychosis / suicide risk / severe dementia) linguistic limitations (such as misunderstanding of the Hebrew language / stuttering / untreated audio impairment) a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities) objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict) subjects whose mother tongue is not Hebrew | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Decompensated Heart Failure males and non-pregnant female patients over 18 years admitted to the hospital or treated in an outpatient heart failure clinic with the primary diagnosis of acute decompensated heart failure evidence of fluid overload more than 8 kg above their dry weight, and conforming to definition of hypervolemia (at least two of the following findings: more than 1+ pitting edema of the lower extremities, jugular venous pressure more than 10 cm water, pulmonary edema or pleural effusion on chest radiograph consistent with ADHF, ascites, paroxysmal nocturnal dyspnea, or equal or more than 2 pillow orthopnea acute coronary syndrome documented ischemic cardiomyopathy atrial fibrillation serum creatinine more than 3.0 mg/dL systolic blood pressure less than 90 mmHg hematocrit > 45% clinical instability likely to require intravenous vasopressors and/or intravenous vasoactive drugs (such as milrinone, dobutamine, nitroglycerin or nesiritide) during the present hospitalization severe pulmonary hypertension or use of pulmonary hypertension drugs (such as sildenafil, bosentan or other endothelin inhibitors) patients with documented hypertrophic obstructive cardiomyopathy or restrictive cardiomyopathy patients with severe valvular heart disease | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Heart Failure Clinical diagnosis of acute heart failure Admitted to the participating hospitals Patients with acute heart failure who are discharged from the emergency room without admission Patients transferred from non-registry hospital Failure to obtain informed consent | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Juvenile Idiopathic Arthritis Subject has been diagnosed with JIA by a pediatric rheumatologist according to published criteria Person providing consent must be able to read English Subject (and/or parent/legal guardian) is able to provide informed consent and willing to comply with study procedures Subject/ legal guardian is unwilling to provide consent, cannot read English, or does not meet published for JIA Coexisting rheumatologic disorder Diagnosis of fibromyalgia Participation in a drug trial in the past 6 months | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 65.0-79.0, Healthy Elderly Subject Pharmacokinetic of YM150 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests Body weight: male: ≥45.0 kg, <85.0 kg; female: ≥40.0 kg, <75.0 kg BMI (at screening): ≥17.6, <30.0 Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.) Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury) Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment) Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma) Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 30.0-70.0, Cervical Spine Degenerative Disc Disease Fusion of Spine, Cervical Region Men and women between the age of 30 to 70 years Individuals who have consulted one of the five participating spine surgeons and are scheduled for ACF surgery at Texas Spine and Joint Hospital Surgical candidates classified as Task Force category III, with neurologic deficit without major structural pathology, or IV, with major structural pathology - Musculoskeletal or systemic disorders with functional impairments that will limit tolerance of testing Pain greater than 8/10 on the NPRS that often indicates severe pathology and therefore limits testing tolerance Prior cervical spine surgeries More than two level cervical spine surgery planned. - | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Congestive Heart Failure Systolic Dysfunction Age =/or >18 Admitted to the Heart Failure Unit with acute decompensated heart failure Referred to the Congestive Heart Failure Disease Management Program Age<18 Mentally incapacitated Discharge to a skilled nursing facility | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-70.0, Sickle Cell Disease Sickle Cell Anemia Regadenoson ARM Diagnosis of sickle cell anemia confirmed by hemoglobin analysis Ages 18 to 70 years Subjects must have laboratory indices as outlined by the protocol Reliable IV access as determined by physician Sickle Cell Controls ARM Diagnosis of sickle cell anemia confirmed by hemoglobin analysis Ages 18 to 70 years Sickle Cell CEU ARM Diagnosis of sickle cell anemia, confirmed by hemoglobin analysis Regadenoson ARM Hospitalization, emergency department visit or self-reported crisis within last 2 weeks for any reason or 4 weeks from acute chest syndrome Current physician diagnosis of active asthma (within last 12 months) or current use of asthma medications Second or third degree AV block or sinus node dysfunction Known or suspected right to left sided cardiac shunts History of a bleeding diathesis History of clinically overt stroke History of severe hypertension not adequately controlled with anti-hypertensive medications Receiving chronic anti-coagulation or anti-platelet therapy History of metastatic cancer | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure History of chronic heart failure Admission for acute decompensated heart failure There is no prespecified criterion with respect to heart failure etiology and/or ejection fraction Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide) Other etiologies of fluid overload different from heart failure Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission Patients requiring inotropic agents or renal replacement therapies Life expectancy < 6 months Prior treatment with thiazide-type diuretics Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation) Pregnancy or breastfeeding period Active alcoholism and/or other substance abuse | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-75.0, Obstructive Sleep Apnoea males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI ≥15/h or sleep apnoea with an ODI ≥5/h plus an Epworth sleepiness score >10 morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with SpO2<90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 60.0-999.0, Heart Failure Patients 60 years of age or older Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography An acute myocardial infarction or unstable angina pectoris within the last three months Valvular stenosis Dementia Severe concomitant disease Refusal to participate | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 40.0-80.0, Hypertension Untreated hypertension: systolic BP ≥ 140 or diastolic BP ≥ 90 mmHg or Treated hypertension Current heart failure symptoms with NYHA class II Evidence of diastolic dysfunction showing any 2 of the following E/E' > 10, LV posterior wall thickness > 11 mm, BNP level > 40 pg/mL Planned cardiac surgery or planned major non-cardiac surgery within the study period Stroke or coronary revascularization in the past 6 months LV ejection fraction < 50% Hypertrophic or restrictive cardiomyopathy, moderate or severe valve disease, constrictive pericarditis Atrial fibrillation with a heart rate > 120/min Sitting systolic BP < 100 mmHg Sitting systolic BP > 160 mmHg or diastolic BP > 95 mmHg despite antihypertensive therapy Significant renal disease manifested by serum creatinine > 2.5 mg/dL Clinically significant pulmonary disease, coronary artery disease A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure, Congestive Cardiovascular Diseases Heart Diseases (PCP) 1. Provider must be the health professional who is managing the potential patient enrollee's heart failure medication(s) (Patients) Participant has been diagnosed with Heart Failure (HF) Self reported family income is less than $30,000/year Has experienced at least one hospitalization for acute, decompensated, HF within the previous 6 months based upon Being admitted for symptoms of HF (ex: peripheral edema, shortness of breath and fatigue), and responding to anti-failure therapy such as diuretics and other anti-failure therapy such as ACE Inhibitors, ARBs, or Beta blockers Has evidence of systolic dysfunction, defined by an ejection <50 by 1 of 3 methods: echocardiography, radiographic contrast ventriculography, or nuclear ventriculography; done within the last year Age ≥ 18 years Currently resides in Cook County, Illinois (PCP) Health providers will be excluded from enrollment if they are Still in their residency or training period A member of the CHART research staff (Patients) Patients will be excluded from enrollment if they have An uncertain 12-month prognosis Listed for imminent cardiac transplant Has an advanced directive of "Do not resuscitate" Has uncertain 12-Month Prognosis, as adjudicated by the Principal Investigator | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-90.0, Cardiovascular Diseases Age between 18 years and 90 years old Clinically significant functional mitral regurgitation (moderate-to-severe or severe mitral regurgitation), as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Assessed by the investigator to be on optimal standard of care therapy for heart failure for at least 4 weeks with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization Documented New York Heart Association Class III or Class IV heart failure, despite optimal standard of care therapy, within 90 days preceding randomization Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of at least 350 pg/mL for BNP or at least 1400 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Left ventricular ejection fraction (LVEF) ≥15% and ≤40% determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Left ventricular end diastolic diameter (LVEDD) ≥55 mm determined by transthoracic echocardiogram within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness Subject agrees to return for all required post-procedure follow-up visits The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative mitral regurgitation), as determined by transesophageal echocardiography Status 1 heart transplant or prior orthotopic heart transplantation Introduction of a new heart failure drug class within the last 4 weeks prior to randomization Cardiovascular hospitalization within the last 2 weeks immediately prior to randomization Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery or atrial fibrillation ablation within 90 days prior to randomization Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD) within 90 days prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization Need for any cardiovascular surgery Mitral valve surgery is considered a therapeutic option for the subject Renal replacement therapy | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-80.0, Constipation Age 18-80 constipation defined by the Rome II Past history of abdominal surgery past history of diabetes mellitus past history of hypothyroidism past history of inflammatory bowel disease past history of significant psychiatric disturbances past history of drug abuse past history of cardiac pacemakers past history of metal implants patients who cannot travel to keep the follow up patients who are prisoners | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 60.0-999.0, Heart Failure Men and women ≥ 60 years Admission to hospital for worsening HF History of uncontrolled hypertension Severe valve disease End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy Advanced chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) < 20 mL/min/1.73 m2 based upon the Modification of Diet in Renal Disease (MDRD) study equation), or on chronic or intermittent dialysis or dialysis anticipated within the next 6 months Chronic anemia with hemoglobin < 9 gm/dl for males, < 8 gm/dl for females or acute anemia requiring transfusion of 2 or more units of blood | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Heart Failure Left Ventricular Dysfunction > 18 years of age Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock) Available for regular follow up Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening Systolic blood pressure <100 mmHg Plan for revascularization Greater than 96 hours after admission Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta) Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-50.0, Obstructive Sleep Apnea Pre-menopausal females aged ≥ 18 years Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry Diagnostic PSG available Diagnosis of mild-moderate OSA (AHI ≤ 30) Participants willing and able to give written informed consent Participants currently using Bi-level PAP Participants currently using supplemental oxygen Participants who are pregnant Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury) Participants who the researcher believes are unsuitable for because either they do not comprehend English they are unable to provide written informed consent they are physically unable to comply with the protocol | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-95.0, Heart Rate Control in ICD Patients With Heart Failure Age ≥ 18 years Patients with stable chronic heart failure implanted with mono-cameral or bicameral ICD with a home monitoring remote control Moderate to severe left ventricular dysfunction (FE ≤ 40%) Any cause of heart failure was allowed apart congenital heart disease Bicameral ICD programmed in DDD or AAI/DDD with AV interval < 300 msec Rest ECG heart rate ≥70 bpm Sinus rhythm In therapy with low-dose of beta-blocker (bisoprolol 1,25-2,5 mg) and with the maximum dose tolerated of angiotensin-converting enzyme inhibitor or blockade of angiotensin II receptor, mineralocorticoid antagonist, antiplatelet and lipid-lowering therapy, unless contraindicated Inability of providing informed consent Age < 18 years State of pregnancy or lactation Recent (<2 months) myocardial infarction Contraindications to beta-blockers and ivabradine Rest ECG heart rate < 70 bpm No sinus rhythm Administration of non-dihydropyridinic calcium channels antagonists, digitalis, class I antiarrhythmic drugs, strong inhibitors of cytochrome P450 3A4 at the time of enrollment | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Metabolic Syndrome Coronary Heart Disease Chronic Heart Failure Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated presence of at least three of five namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy) Patients with documented stable chronic heart failure will be recruited if they show the following ≥18 years Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography) NYHA functional class I-III Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation) Able to perform an symptom limited exercise test Capacity and willingness to sign the informed consent form For healthy elderly subjects age under 60 years lack of expressed written consent metabolic syndrome coronary heart disease chronic systolic heart failure resting left ventricular ejection fraction < 40 % symptomatic aortic stenosis chronic atrial fibrillation malignant exertional arrhythmias | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-130.0, Heart Failure All 6 need to be met for enrollment of the patient in the study Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below dyspnea or respiratory distress or tachypnea at rest or with minimal exertion evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met) pulmonary congestion/edema at physical exam OR chest X-Ray plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months) The patient is now clinically stable and meets standard for hospital discharge as documented by all the 3 conditions listed below absence of dyspnea or pulmonary congestion/distress at rest Subjects will not be eligible if they meet any of the following 15 The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy or brady-arrhythmias Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries Previous or planned implantation of left ventricular assist devices or heart-transplant Chronic use of intravenous inotropes Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]) Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Decompensated Heart Failure Heart Failure Patients ≥ 18 years of age and English-speaking who are admitted to the General Cardiology or Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure (ADHF) Patients deemed by the health care team to require hemodynamic monitoring with a pulmonary artery catheter and inotropic therapy. Patients receiving at least 3 doses of continued beta blocker therapy with carvedilol, metoprolol succinate, or metoprolol tartrate and patients receiving no beta blocker therapy or have missed at least 5 doses of beta-blocker therapy Concomitant treatment with other beta blockers, non-selective alpha blockers (e.g. terazosin, prazosin, doxazosin), non-dihydropyridine calcium antagonists, antiarrhythmic agents except for chronic stables doses of amiodarone, dofetilide or mexiletine Use of inotropes or IV vasoactive agents within 7 days or at time of enrollment Patients with hemodynamically unstable arrhythmias (e.g., Systolic Blood Pressure (SBP) < 80, Heart Rate (HR) > 110), uncorrected primary valvular disease, or current mechanical support including left ventricular assist device (LVADs), Impella devices and balloon pumps Patients who have missed more than 1 dose of beta blocker within 72 hours of starting inotrope No subjects will be excluded based upon race, gender or ethnicity | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 7.0-999.0, Limb Girdle Muscular Dystrophy Type 2D (LGMD2D) Subjects age 7 or older; cohort 1A must be adult and wheelchair-dependent Proven alpha-sarcoglycan deficiency by muscle biopsy or DNA testing Onset of weakness by 5 years age based on history of difficulty running, jumping and climbing stairs Subject enrolled in Cohort 1A must be adult and wheelchair dependent Subjects enrolled in Cohorts 1B or 2 must be able to walk independently, but must exhibit signs of lower extremity weakness (i.e. a Gowers' sign, use a handrail for climbing stairs) and walk ≤ 80% of predicted distance on the 6MWT based on normative data Males and females of any ethnic group will be eligible Ability to cooperate with muscle testing Willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception (If appropriate), during the first six months after gene therapy (females) or until two negative sperm samples are obtained post gene transfer (males) Active viral infection based on clinical observations The presence of SGCA mutations without weakness or loss of function Symptoms or signs of cardiomyopathy, including Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs Echocardiogram with ejection fraction below 40% Serological evidence of HIV infection, or Hepatitis A, B or C infection Diagnosis of (or ongoing treatment for) an autoimmune disease Abnormal laboratory values considered clinically significant (GGT > 3XULN, bilirubin ≥ 3.0 mg/dL , creatinine ≥ 1.8 mg/dL, Hgb < 8 or > 18 g/Dl; WBC > 15,000 per cmm) Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer Pregnancy | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 40.0-90.0, Congestive Heart Failure Congestive heart failure patients between tne ages 40 to 90,all stages of the disease non | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 20.0-75.0, Obstructive Sleep Apnoea (OSA) Confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI) of >20/h Currently >20/h oxygen desaturations (≥4% dips) during an ambulatory nocturnal pulse oximetry performed on the last night of a 4-night period without CPAP Treated with CPAP for more than 12 months, minimum compliance 4h/night, apnoea-hypopnoea index (AHI) <10 with treatment (according to CPAP download) and current ESS <10 Age between 20 and 75 years at trial entry Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa) Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg) Previously diagnosed with Cheyne-Stokes breathing Current professional driver; any previous sleep related accident Acute inflammatory disease Acute or chronic hepatic disease Renal failure or renal replacement therapy Use of inhaled drugs | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 21.0-999.0, Congestive Heart Failure CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD) Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease Subjects with acute decompensated heart failure currently on nesiritide therapy Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and Subjects unable to or refusing to provide written informed consent | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Asthma Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 75.0-999.0, Heart Failure years or older diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure' diagnosis had to be confirmed by a recent echocardiogram not Dutch speaking treatment restrictions had been applied on admission | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Beta Blocker Intolerance; Congestive Heart Failure Patients on optimal therapy for heart failure (diuretics, ACE inhibitors and aldosterone antagonists), with stable dose in the previous month Successfully implanted with CRT-D according to current European Society of Cardiology (ESC) guidelines New York Heart Association (NYHA) functional class: II, III and IV Left Ventricular Ejection Fraction (LVEF) ≤ 35% Duration of ventricular depolarization wave (QRS) ≥ 120ms (NYHA III or IV) or ≥ 150ms in NYHA II Patients with chronic atrial fibrillation will be eligible for the study only if they undergo ablation years or above Failure to comply with the scheduled follow-up Life expectancy less than 12 months Pregnant women Tricuspid valve mechanics Severe aortic stenosis or other valve disease Patients already receiving CRT | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD Current smokers or ex-smokers A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5% BDI score ≤ 10 Patients free of exacerbations for at least 1 month Pregnant or lactating women Diagnosis of asthma Patients treated for exacerbations in the 4 weeks prior to screening visit Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia Known respiratory disorders other than COPD Patients who have clinically significant cardiovascular condition | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Sleep Disordered Breathing Heart Failure Heart failure with reduced ejection fraction (<40%) Either no significant sleep disordered breathing or moderate to severe CSA Able to consent to the study Ambulatory Aged 18-100 years Patients on Non-Invasive Ventilation Predominant OSA Unable to consent or attend for the study | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 12.0-999.0, Gastroesophageal Reflux Disease GERD Gastroparesis Male or female Age 12 and older Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy Patients must have a comprehensive evaluation to eliminate other causes of their symptoms Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including increased prolactin levels extrapyramidal side effects breast changes cardiac arrhythmias including QT prolongation and death There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females) Clinically significant electrolyte disorders Gastrointestinal hemorrhage or obstruction Presence of a prolactinoma (prolactin-releasing pituitary tumor) Pregnant or breast feeding female Known allergy to domperidone | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Acute Decompensated Heart Failure Congestive Heart Failure Compensated Age ≥ 18 years, AND Written informed consent by patient or nearest relative where appropriate, AND Either Referred for echocardiography, OR At least one typical symptom and one typical sign consistent with possible heart failure, OR Healthy volunteers Age <18 years Prior enrollment in study Patients with known or suspected pregnancy | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-75.0, Asthma History of asthma ≥ 5 years and diagnosed before 40 years old Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5 Pre-bronchodilator FEV1 ≥40% and <90% of their predicted normal value Positive reversibility test Pregnant or lactating women Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Patients treated for asthma exacerbation in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition | 0 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure years and older History of heart failure with an LVEF (less than OR equal to) < 0.35 for at least 6 months OR an LVEF < 0.45 with left ventricular internal end diastole (defined by a diameter of more than 2.9 cm per square meter of body surface area OR more than 6.5 cm on the basis of echocardiography) New York Heart Association (NYHA) Class II-IV Background heart failure therapy that includes angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs), and beta blockers (BBs) for at least 3 months (or documentation of intolerance to ACEi/ARBs and BBs) No history of intolerance to either nitrates or hydralazine No treatment with the combination of hydralazine and nitrates for the previous 3 months No revascularization or myocardial infarction within last 90 days Can not be enrolled for at least 90 days after receiving cardiac resynchronization therapy (CRT) AND must have an LVEF (less than OR equal to) < 0.35 at least 3 months after CRT Presence of clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy, active myocarditis, or uncontrolled hypertension Women who are currently pregnant, planning on becoming pregnant in the next two years, or those who do not agree to prevent pregnancy | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 0.0-999.0, Congestive Heart Failure Heart Failure, Diastolic Heart Failure, Systolic Elderly Frail Guideline Adherence All patients who admitted to the participating centers due to acutly decompensated CHF defined by modified Framingham Patients who underwent heart failure treatment including intravenus drug | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure University of Michigan patients hospitalized for the treatment of heart failure, within the past 30 days Patients must be receiving an oral loop diuretic on their home regimen or have received intravenous loop diuretic during the index hospitalization at the time of enrollment Patients must have an assessment of left ventricular function within the previous 2 years Patients must have LVEF ≤ 40%, or LVEF >40 with evidence of left atrial enlargement (LA dimension > 40 mm), BNP > 200 ng/ml or PCW > 18 mmHg Prisoners Residents of long term nursing facilities Enrollment into a hospice program Receiving dialysis Patients with dementia Patients with dGFR less than 20ml/min Patients being worked up for heart surgery Patients being worked up for heart transplant Patients being evaluated for revasuculariztion Patients being evaluated for heart valve intervention | 1 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-999.0, Heart Failure Patients admitted with symptomatic heart failure, diagnosed within 2 years Diagnosis of congestive heart failure using the modified Framingham Simultaneous presence of at least 2 major or 1 major criterion in conjunction with 2 minor or a previous clear diagnosis of heart failure Major Paroxysmal nocturnal dyspnea or orthopnea Neck vein distention Rales/Crackles (>10 cm from base of lungs) Acute pulmonary edema S3 gallop Increased central venous pressure (>16 cm H2O at right atrium) Patients unable to provide blood sample Patients unable to provide consent Patient with life expectancy of less than 6 months, or has major co-morbidities Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial Participants who have participated in another research trial involving an investigational product in the past 30 days | 2 |
A 65 yo African-American male with shortness of breath related to exertion that has been worsening over the past three weeks. He also has difficulty breathing when lying flat and has started using two to three extra pillows at night. Significant physical exam findings include bibasilar lung crackles, pitting ankle edema and jugular venous distension. | eligible ages (years): 18.0-45.0, Preeclampsia Exposed cases African American women who are admitted to the obstetrical unit with a concern for severe preeclampsia. Patients must be preterm (23-36 6/7 weeks) with a live singleton gestation and at least 18 years old. Women will baseline chronic hypertension and women on magnesium will be included Non-African American women, and African women with concern for severe preeclampsia who are admitted 23 weeks or 37 weeks. Women in labor will be excluded. Women with preexisting cardiovascular disease and women who are current smokers will be excluded Unexposed controls African American women obtaining prenatal care in our outpatient setting who meet matching as noted above Non-African American women and women who are not receiving care at our institution All women who do not speak English and who are unable to be consented will be excluded | 0 |
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