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Updated: Aug 19, 2025

Author Spotlight: Exercise Test for Evaluation of the Functional Efficacy of the Pig Cardiovascular System
Published on: May 12, 2023
Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel
Mitchell A Psotka1, William T Abraham2, Mona Fiuzat3
1Inova Heart and Vascular Institute, Falls Church, Virginia, USA; U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Abstract:
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations.
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