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Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.

Publication ,  Journal Article
Psotka, MA; Abraham, WT; Fiuzat, M; Filippatos, G; Lindenfeld, J; Ahmad, T; Felker, GM; Jacob, R; Kitzman, DW; Leifer, ES; Lewis, EF; Ni, W ...
Published in: JACC Heart Fail
December 2022

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.

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Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

December 2022

Volume

10

Issue

12

Start / End Page

889 / 901

Location

United States

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
 

Citation

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Psotka, M. A., Abraham, W. T., Fiuzat, M., Filippatos, G., Lindenfeld, J., Ahmad, T., … O’Connor, C. M. (2022). Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. JACC Heart Fail, 10(12), 889–901. https://doi.org/10.1016/j.jchf.2022.09.012
Psotka, Mitchell A., William T. Abraham, Mona Fiuzat, Gerasimos Filippatos, JoAnn Lindenfeld, Tariq Ahmad, G Michael Felker, et al. “Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.JACC Heart Fail 10, no. 12 (December 2022): 889–901. https://doi.org/10.1016/j.jchf.2022.09.012.
Psotka MA, Abraham WT, Fiuzat M, Filippatos G, Lindenfeld J, Ahmad T, et al. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. JACC Heart Fail. 2022 Dec;10(12):889–901.
Psotka, Mitchell A., et al. “Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel.JACC Heart Fail, vol. 10, no. 12, Dec. 2022, pp. 889–901. Pubmed, doi:10.1016/j.jchf.2022.09.012.
Psotka MA, Abraham WT, Fiuzat M, Filippatos G, Lindenfeld J, Ahmad T, Felker GM, Jacob R, Kitzman DW, Leifer ES, Lewis EF, Mentz RJ, Nkulikiyinka R, Ni W, Schaber DE, Sharma A, Solomon SD, Stockbridge N, Teerlink JR, Unger EF, Whellan DJ, Wittes J, Anker SD, O’Connor CM. Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel. JACC Heart Fail. 2022 Dec;10(12):889–901.
Journal cover image

Published In

JACC Heart Fail

DOI

EISSN

2213-1787

Publication Date

December 2022

Volume

10

Issue

12

Start / End Page

889 / 901

Location

United States

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