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NCT00894387

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

Last Updated: 2013-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Acute Decompensated Heart Failure Congestive Heart Failure

Keywords

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BNP KCCQ eGFR 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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aliskiren

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.

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Aliskiren 150 mg and Aliskiren 300 mg

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Aliskiren

Aliskiren 150 mg and Aliskiren 300 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Aliskiren®, Tekturna®, Rasilez®, SPP100

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis Investigative Site

Mobile, Alabama, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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San Diego, California, United States

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Sylmar, California, United States

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Torrance, California, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Macon, Georgia, United States

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Oakbrook Terrace, Illinois, United States

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Iowa City, Iowa, United States

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Lafayette, Louisiana, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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St Louis, Missouri, United States

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Cherry Hill, New Jersey, United States

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Newark, New Jersey, United States

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Buffalo, New York, United States

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Buffalo, New York, United States

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Saratoga Springs, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Rapid City, South Dakota, United States

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Springfield, Tennessee, United States

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Brownsville, Texas, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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