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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
PubMed

Insights

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.

Keywords:
clinical trialfunctional endpointheart failureintermediate endpointsurrogate endpoint

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