Functional and Symptomatic Clinical Trial Endpoints
2022; Elsevier BV; Volume: 10; Issue: 12 Linguagem: Inglês
10.1016/j.jchf.2022.09.012
ISSN2213-1787
AutoresMitchell A. Psotka, William T. Abraham, Mona Fiuzat, Gerasimos Filippatos, JoAnn Lindenfeld, Tariq Ahmad, G. Michael Felker, Richard Jacob, Dalane W. Kitzman, Eric Leifer, Eldrin F. Lewis, Robert J. Mentz, Richard Nkulikiyinka, Wei Ni, Daniel E. Schaber, Abhinav Sharma, Scott D. Solomon, Norman Stockbridge, John R. Teerlink, Ellis F. Unger, David J. Whellan, Janet Wittes, Stefan D. Anker, Christopher M. O’Connor,
Tópico(s)Health Systems, Economic Evaluations, Quality of Life
ResumoThe 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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