Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure; Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Aliskiren; Placebo
Intervention description: Aliskiren 150 mg and Aliskiren 300 mg; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1639.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        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.

        Other protocol-defined inclusion/exclusion criteria applied.