Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.
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.
Duke Scholars
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- United States
- Research Personnel
- Quality of Life
- National Institutes of Health (U.S.)
- Humans
- Heart Failure
- Exercise Tolerance
- 3201 Cardiovascular medicine and haematology
- 1102 Cardiorespiratory Medicine and Haematology
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- United States
- Research Personnel
- Quality of Life
- National Institutes of Health (U.S.)
- Humans
- Heart Failure
- Exercise Tolerance
- 3201 Cardiovascular medicine and haematology
- 1102 Cardiorespiratory Medicine and Haematology