The following is a summary of “Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel” published in the December 2022 issue of Heart Failure by Psotka, et al.
The Heart Failure Academic Research Consortium is a collaboration between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC), and it is made up of patients, academic investigators from the United States and Europe, the United States Food and Drug Administration, the National Institutes of Health, payers, and industry.
Members discussed the measurement, remote capture, and clinical utility of functional and quality-of-life endpoints for use in heart failure and cardiovascular therapeutics clinical trials, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and, as a result, patient quality of life, functional status, and survival.
Patient-reported outcomes and maximal and submaximal exercise tolerance assessments are standardized and validated, but actigraphy as a potential endpoint remains inconsistent. This paper describes those discussions and the recommendations reached by consensus.