Description:

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT) See http://clinicaltrials.gov/ct2/show/record/NCT00894387

Link:

http://clinicaltrials.gov/ct2/show/record/NCT00894387

Keywords:
Versions (3) ▾
  1. 11/18/11
  2. 3/26/14
  3. 4/13/14
Uploaded on:

April 13, 2014

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License:
Creative Commons BY 4.0
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Eligibility NCT00894387 Heart Failure

Details

Eligibility Heart failure NCT00894387

Inclusion criteria
primary diagnosis of worsening heart failure
age >= 18 years
acute heart failure symptoms (dyspnea or fatigability - NYHA Class III-IV) and signs of fluid overload (i.e., jugular venous distension, edema or positive rales auscultation or pulmonary congestion on chest x-ray) at the time of hospitalization
LVEF less than 40% (measured within the last 6 months)
Hospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP >= 110 mm Hg after acute decompensated episode) and did not receive IV vasodilators (other than nitrates) and/or IV inotropic drugs at anytime from ADHF presentation to time of randomization
Elevated BNP at Visit 1 or at randomization (BNP >= 400 pg/ml)
Patients with a history of chronic heart failure on standard therapy defined as requiring HF treatment for at least 30 days before the current hospitalization (NYHA Class II - IV).
Exclusion criteria
Patients that required any use of IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for worsening HF to randomization.
Concomitant use of ACEI and ARB at randomization.
Right heart failure due to pulmonary disease.
Diagnosis of postpartum cardiomyopathy.
Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
Patients with a history of heart transplant or who are on a transplant list.
Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
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