A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate 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)

NCT00894387 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	1639
Start date	2009-05
Completion	2012-08

Conditions

• Acute Decompensated Heart Failure
• Congestive Heart Failure

Interventions

• Aliskiren
• Placebo

Primary outcomes

• Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months — 6 months
  Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.

Countries

United States, Argentina, Belgium, Brazil, Canada, Colombia, Czechia, Finland, France, Germany, Hungary, India, Israel, Italy, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey (Türkiye)