Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure Cardiovascular death CHF hospitalization morbi-mortality trial outcome study endpoint driven plasma renin activity renin angiotensin aldosterone system direct renin inhibitors BNP KCCQ eGFR (NYHA class II to IV) with elevated BNP and reduced LVEF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7064
Healthy volunteers: no

Brief summary:
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

Detailed description:

Arms:
arm 1: Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally. arm 2: Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally. arm 3: Enalapril monotherapy -10 mg film-coated tablet and administered orally.

Interventions: intervention 1: Enalapril intervention 2: Aliskiren
Intervention descriptions: intervention 1: Enalapril 10 mg film-coated tablet and administered orally. intervention 2: Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.

Protocol document: