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
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
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.
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.
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:
Other protocol-defined inclusion/exclusion criteria applied.
Buenos Aires, Buenos Aires B1650CSQ, Argentina
Buenos Aires, Buenos Aires B1708KCH, Argentina
Buenos Aires, Buenos Aires C1050AAK, Argentina
Buenos Aires, Buenos Aires C1094AAD, Argentina
Buenos Aires, Buenos Aires C1201AAO, Argentina
Buenos Aires, Buenos Aires C1210AAP, Argentina
Buenos Aires, Buenos Aires C1428AQK, Argentina
Buenos Aires, Buenos Aires W3400ABH, Argentina
Buenos Aires, Buenos Aires, Argentina
Bogotá, Cundinamarca, Colombia
Secunderabad, Andhra Pradesh 500003, India
Lódz, 91-347, Poland
S.-Petersburg, 192242, Russia
S.-Petersburg, 195197, Russia
S.-Petersburg, 196247, Russia
S.-Petersburg, 198205, Russia
Kosice-Saca, 040 01, Slovakia
Majadanonda, Madrid 28220, Spain
Lin-Ko, 33305, Taiwan
Atakum / Samsun, 55139, Turkey (Türkiye)
Etlik / Ankara, 06018, Turkey (Türkiye)
Talas / Kayseri, 38039, Turkey (Türkiye)