Conditions: Acute Decompensated Heart Failure Congestive Heart Failure
Keywords: elevated BNP reduced LVEF Acute 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1639
Healthy volunteers: no

Brief summary:
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.

Detailed description:

Arms:
arm 1: Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy. arm 2: Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.

Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: Aliskiren 150 mg and Aliskiren 300 mg intervention 2: Placebo

Protocol document: