A 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

Novartis Healthcare Private Limited19 个研究点分布在 1 个国家目标入组 2,126 人开始时间: 2009年5月22日最近更新: 2014年9月4日

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Healthcare Private Limited
入组人数: 2,126
试验地点: 19
主要终点: Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months

Target number of patients from India is 150.Expected date of enrollment from India is 17th August 2009.

•*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. oLVEF < 40% (measured within the last 6 months). oHospitalization 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.

•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.

Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months

时间窗: Time Frame: 6 months

Delay time of first occurrence of either cardiovascular death or heart failure re-hospitalization through end of study(Time Frame: 6 months)
? Change in the clinical summary score (assessed by KCCQ) from baseline to 1 month, 6 months and end of study(Time Frame: 6 months)

发起方

申办方类型

Pharmaceutical industry-Global

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