Evaluating the Efficacy,Safety, and Tolerability of Serelaxin When Added to Standard Therapy in Asian Patients With Acute Heart Failure: Design and Rationale of RELAX-AHF-ASIA Trial |
| |
Authors: | Naoki Sato Carolyn SP Lam John R Teerlink Barry H Greenberg Hiroyuki Tsutsui Byung-Hee Oh Jian Zhang Martin Lefkowitz Tsushung A Hua Thomas Holbro Miriam Marshood Xing Li Wang Junbo Ge |
| |
Institution: | 1. Cardiology and Intensive Care Unit, Nippon Medical School, Musashi-Kosugi Hospital, Kawasaki, Japan;2. National Heart Centre Singapore and Duke-NUS, Singapore;3. University of California, San Francisco, and San Francisco Veterans Affairs Medical Center, Los Angeles, California;4. Division of Cardiology, University of California, San Diego, La Jolla, California;5. Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan;6. Department of Internal Medicine, Seoul National University, College of Medicine, Seoul, South Korea;7. Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People''s Republic of China;8. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey;9. Novartis Pharma, Basel, Switzerland;10. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China |
| |
Abstract: | BackgroundAcute heart failure (AHF), a common and growing health concern worldwide, is associated with high risk of post-discharge rehospitalization and mortality. Existing evidence indicates potential therapeutic benefits of serelaxin in Caucasian AHF patients, but corresponding data in Asians remain scarce. RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments.Methods and ResultsPatients with AHF, systolic blood pressure ≥125?mm?Hg, and mild to moderate renal dysfunction will be randomized within 16 hours of presentation to receive 48-hour intravenous infusion of 30?µg ? kg?1 ? d?1 serelaxin or placebo in addition to standard therapy. The composite primary end point includes: (1) treatment success (moderate/marked improvement in patient-reported dyspnea and physician-assessed signs of congestion on day 2); (2) treatment failure (in-hospital worsening of signs and/or symptoms of heart failure HF] requiring intensification of intravenous HF therapy or mechanical ventilation, renal/circulatory support, rehospitalization due to HF/renal-failure, or death through day 5); and (3) unchanged status. Secondary end points include time to in-hospital worsening HF through day 5 and all-cause and cardiovascular deaths through day 180.ConclusionsRELAX-AHF-ASIA, the largest randomized clinical trial in Asian AHF patients to date, has a novel composite primary end point and the potential to become a hallmark of AHF trials. |
| |
Keywords: | Serelaxin efficacy Asian acute heart failur |
本文献已被 ScienceDirect 等数据库收录! |
|