Consensus recommendations highlight that while patient-reported outcomes and exercise tolerance are standardized for heart failure trials, actigraphy remains inconsistent as a potential endpoint.
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.
Psotka et al. (Wed,) conducted a review in Heart failure. Consensus recommendations highlight that while patient-reported outcomes and exercise tolerance are standardized for heart failure trials, actigraphy remains inconsistent as a potential endpoint.