Endpoints in Heart Failure Drug Development: History and Future

JACC Heart Fail. 2020 Jun;8(6):429-440. doi: 10.1016/j.jchf.2019.12.011. Epub 2020 Apr 8.


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.

Keywords: FDA; clinical trials; endpoints; heart failure; patient-reported outcomes.

Publication types

  • Historical Article
  • Review

MeSH terms

  • Cardiovascular Agents / history*
  • Cardiovascular Agents / pharmacology
  • Drug Approval / history
  • Drug Development / history*
  • Health Status*
  • Heart Failure / drug therapy
  • Heart Failure / history*
  • History, 20th Century
  • History, 21st Century
  • Humans
  • United States


  • Cardiovascular Agents