Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Disease and Death in Patients With Acute Decompensated Heart Failure (ASTRONAUT)

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000459

Enrollment

2126

Registered

2009-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Decompensated Heart Failure Congestive Heart Failure

Interventions

Intervention1: Aliskiren: 150 milligram &amp

300 milligram film coated tablets Control Intervention1: Placebo: Placebo to match aliskiren 150 milligram & 300 milligram film coated tablets taken orally in the morning throughout the entire durati

Eligibility

Inclusion criteria

Inclusion criteria: *Patient hospitalized with a primary diagnosis of worsening heart failure &#8805; 18 years of age, male or female. *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. oLVEF < 40% (measured within the last 6 months). oHospitalization for ADHF and remain "stabilized" for at least 6 hours (defined as SBP &#8805; 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 &#8805; 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

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 PTCA before randomization.

Design outcomes

Primary

Measure	Time frame
Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 monthsTimepoint: Time Frame: 6 months	—

Secondary

Measure	Time frame
Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization through end of studyTimepoint: Time Frame: 6 months;? Change in the clinical summary score (assessed by KCCQ) from baseline to 1 month, 6 months and end of studyTimepoint: Time Frame: 6 months	—

Countries

Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Finland, France, Germany, Hungary, India, Iraq, Israel, Italy, Philippines, Poland, Romania, Singapore, Slovakia, Spain, Sweden, Taiwan, Turkey

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026