A multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaulate the 6 months efficacy and safety of aliskiren therapy on top of standard therapy, on morbidity and mortality when initiated early after hospitalization for acute decompensated heart failure. - Astronaut

• Conditions: Acute decompensated heart failure; MedDRA version: 9.1Level: LLTClassification code 10000803Term: Acute heart failure

• Registration Number: EUCTR2009-010236-18-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-04
• Last Update Posted: 26 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1782

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Patient hospitalized with a primary diagnosis of worsening heart failure = 18 years of age, male or female.
2.Patients with a diagnosis of acute heart failure expressed by 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 < 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.
3.Elevated BNP at Visit 1 (BNP = 400 pg/ml)
4.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)
5.Written informed consent to participate in the study.
6.Ability to comply with all study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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
2.Concomitant use of ACEI and ARB at randomization
3.Right heart failure due to pulmonary disease
4.Diagnosis of postpartum cardiomyopathy
5.Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
6.Patients with a history of heart transplant or who are on a transplant list
7.Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) before randomization.
8.Sustained ventricular arrhythmia with syncopal episodes within past 3 months that is untreated
9.Presence of hemodynamically significant mitral stenosis or mitral regurgitation, except mitral regurgitation secondary to left ventricular dilatation
10.Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis
11.Persistent systolic blood pressure < 110 mm Hg
12.Stroke within the past 3 months
13.Primary liver disease considered to be life threatening
14.Serum potassium > 5.0 mEq/L (5.0 mmol/L) at Visit 2
15.Severe hyponatremia < 130 meq/l at Visit 2
16.Renal disease or eGFR < 40 ml/min/1.73m2 (as measured by the MDRD formula) at Visit 2. See other criteria in the protocol page 24-25.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified