Status:
COMPLETED
Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Decompensated Heart Failure
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1639 Patients enrolled
Trial Details
Trial ID
NCT00894387
Start Date
May 1 2009
End Date
August 1 2012
Last Update
November 7 2013
Active Locations (308)
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1
Novartis Investigative Site
Mobile, Alabama, United States, 36608
2
Novartis Investigative Site
Tucson, Arizona, United States, 85723-0001
3
Novartis Investigative Site
Los Angeles, California, United States, 90073
4
Novartis Investigative Site
San Diego, California, United States, 92103