Journal
JACC-HEART FAILURE
Volume 8, Issue 6, Pages 429-440Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.jchf.2019.12.011
Keywords
clinical trials; endpoints; FDA; heart failure; patient-reported outcomes
Categories
Ask authors/readers for more resources
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, white 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. (C) 2020 Published by Elsevier on behalf of the American College of Cardiology Foundation.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available