Endpoints in Heart Failure Drug Development: History and Future.

Journal Article (Journal Article;Review)

Heart failure (HF) patients experience a high burden of symptoms and functional limitations, and morbidity and mortality remain high despite successful therapies. The majority of HF drugs in the United States are approved for reducing hospitalization and mortality, while only a few have indications for improving quality of life, physical function, or symptoms. Patient-reported outcomes that directly measure patient's perception of health status (symptoms, physical function, or quality of life) are potentially approvable endpoints in drug development. This paper summarizes the history of endpoints used for HF drug approvals in the United States and reviews endpoints that measure symptoms, physical function, or quality of life in HF patients.

Full Text

Duke Authors

Cited Authors

  • Fiuzat, M; Lowy, N; Stockbridge, N; Sbolli, M; Latta, F; Lindenfeld, J; Lewis, EF; Abraham, WT; Teerlink, J; Walsh, M; Heidenreich, P; Bozkurt, B; Starling, RC; Solomon, S; Felker, GM; Butler, J; Yancy, C; Stevenson, LW; O'Connor, C; Unger, E; Temple, R; McMurray, J

Published Date

  • June 2020

Published In

Volume / Issue

  • 8 / 6

Start / End Page

  • 429 - 440

PubMed ID

  • 32278679

Electronic International Standard Serial Number (EISSN)

  • 2213-1787

Digital Object Identifier (DOI)

  • 10.1016/j.jchf.2019.12.011


  • eng

Conference Location

  • United States