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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.
JACC. Heart Failure
|December 1, 2022
Summary
The Heart Failure Academic Research Consortium (HFC and ARC) explored functional and quality-of-life endpoints for heart failure trials. Standardized patient-reported outcomes and exercise tests are useful, but actigraphy needs further validation for clinical research.
Area of Science:
- Cardiology
- Clinical Research Methodology
Background:
- Heart failure clinical research requires efficient and reliable endpoints.
- Existing endpoints for functional status and quality of life need evaluation for clinical trial utility.
Purpose of the Study:
- To discuss and establish consensus on functional and quality-of-life endpoints for heart failure and cardiovascular therapeutics clinical trials.
- To improve the efficiency of clinical research, evidence generation, and patient outcomes in heart failure.
Main Methods:
- Consensus discussions among diverse stakeholders including patients, academic investigators, regulatory bodies (FDA, NIH), payers, and industry.
- Evaluation of the measurement, remote capture, and clinical utility of various endpoints.
Main Results:
- Patient-reported outcomes and exercise tolerance tests (maximal and submaximal) are standardized and validated for clinical trials.
- Actigraphy shows potential but currently lacks consistent validation as a reliable endpoint.
Conclusions:
- Standardized patient-reported outcomes and exercise testing are recommended endpoints for heart failure trials.
- Further research and standardization are needed to establish actigraphy as a consistent clinical trial endpoint.
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