| Literature DB >> 33017862 |
William T Abraham1, Mitchell A Psotka2, Mona Fiuzat3, Gerasimos Filippatos4, JoAnn Lindenfeld5, Roxana Mehran6, Amrut V Ambardekar7, Peter E Carson8, Richard Jacob9, James L Januzzi10, Marvin A Konstam11, Mitchell W Krucoff3, Eldrin F Lewis12, Jonathan P Piccini3, Scott D Solomon13, Norman Stockbridge14, John R Teerlink15, Ellis F Unger13, Emily P Zeitler16, Stefan D Anker17, Christopher M O'Connor2,3.
Abstract
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. © Copyright 2020 European Society of Cardiology and American College of Cardiology.Entities:
Keywords: Clinical trial; Definitions; Endpoints; Heart failure
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Year: 2020 PMID： 33017862 DOI： 10.1002/ejhf.2018
Source DB: PubMed Journal: Eur J Heart Fail ISSN： 1388-9842 Impact factor: 15.534