Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium. (13th November 2020)

• Record Type: Journal Article
• Authors: Abraham, William T.; Psotka, Mitchell A.; Fiuzat, Mona; Filippatos, Gerasimos; Lindenfeld, JoAnn; Mehran, Roxana; Ambardekar, Amrut V.; Carson, Peter E.; Jacob, Richard; Januzzi, James L.; Konstam, Marvin A.; Krucoff, Mitchell W.; Lewis, Eldrin F.; Piccini, Jonathan P.; Solomon, Scott D.; Stockbridge, Norman; Teerlink, John R.; Unger, Ellis F.; Zeitler, Emily P.; Anker, Stefan D.; O'Connor, Christopher M.
• Is Part Of: European journal of heart failure. Volume 22:Number 12(2020)
• Page Start: 2175
• Page End: 2186
• Publication Date: 2020-11-13
• Subjects: Heart failure -- Clinical trial -- Endpoints -- Definitions; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.2018
• Languages: English
• ISSNs: 1388-9842

Abstract

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.