Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Decompensated Heart Failure, Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT00894387

Run by

Novartis Pharmaceuticals

People needed

1639

Starts

2009-05-01

Expected to finish

2012-08-01

Last updated by the study team

2013-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient hospitalized with a primary diagnosis of worsening heart failure ≥ 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.
• 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.
• Elevated BNP at Visit 1 or at randomization (BNP ≥ 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).

You may not qualify if…

• 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.
• Concomitant use of ACEI and ARB at randomization.
• Right heart failure due to pulmonary disease.
• Diagnosis of postpartum cardiomyopathy.
• Myocardial infarction or cardiac surgery, including percutaneous transluminal coronary angioplasty (PTCA), within past 3 months.
• Patients with a history of heart transplant or who are on a transplant list.
• Unstable angina or coronary artery disease likely to require coronary artery bypass graft (CABG) or PTCA before randomization.
• Other protocol-defined inclusion/exclusion criteria applied.

Where it is running

• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Sylmar, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Hartford, Connecticut, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Macon, Georgia, United States
• Novartis Investigative Site — Oakbrook Terrace, Illinois, United States
• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigative Site — Lafayette, Louisiana, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Kalamazoo, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Cherry Hill, New Jersey, United States
• Novartis Investigative Site — Newark, New Jersey, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — Saratoga Springs, New York, United States
• Novartis Investigative Site — The Bronx, New York, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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