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


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 5, 2009)		Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00894387 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 5, 2009)
  • Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization through end of study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in the clinical summary score (assessed by KCCQ) from baseline to 1 month, 6 months and end of study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESix Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Official Title  ICMJEA 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
Brief Summary

This study will evaluate 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 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJE
  • Acute Decompensated Heart Failure
  • Congestive Heart Failure
Intervention  ICMJE
  • Drug: Aliskiren
    Aliskiren 150 mg and Aliskiren 300 mg
  • Drug: Placebo
    Placebo
Study Arms / Comparison Groups
  • 1: Experimental
    Aliskiren 150 mg and Aliskiren 300 mg
    Intervention: Drug: Aliskiren
  • 2: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1782
Completion Date 
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 may apply.

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis862-778-8300
Location Countries  ICMJEUnited States,   Argentina,   Belgium,   Brazil,   Canada,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Turkey

Administrative Information

NCT ID  ICMJENCT00894387
Responsible PartyExternal Affairs, Novartis
Study ID Numbers  ICMJECSPP100A2368
Study Sponsor  ICMJENovartis
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:NovartisNovartis
Information Provided ByNovartis