Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
Inova Heart and Vascular Institute, Falls Church, Virginia, USA.
JACC Heart Fail. 2020 Dec;8(12):961-972. doi: 10.1016/j.jchf.2020.10.002. Epub 2020 Nov 13.
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.
心力衰竭学术研究联合会是心力衰竭协作组（HFC）与学术研究联合会（ARC）之间的合作伙伴关系，由领先的心力衰竭（HF）学术研究调查人员、患者、美国（美国）食品和药物管理局代表以及来自美国和欧洲的行业成员组成。召开了一系列会议，以确定心力衰竭治疗评估的定义和关键概念，包括最佳药物和器械背景治疗、临床试验设计要素和统计概念以及研究终点。本手稿总结了专家小组的讨论，作为关注人群和终点定义的共识建议；它不是详尽无遗或具有限制性的，而是旨在激发心力衰竭临床试验的创新。
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