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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. Copyright © 2020. Published by Elsevier Inc.


Mona Fiuzat, Naomi Lowy, Norman Stockbridge, Marco Sbolli, Federica Latta, JoAnn Lindenfeld, Eldrin F Lewis, William T Abraham, John Teerlink, Mary Walsh, Paul Heidenreich, Biykem Bozkurt, Randall C Starling, Scott Solomon, G Michael Felker, Javed Butler, Clyde Yancy, Lynne W Stevenson, Christopher O'Connor, Ellis Unger, Robert Temple, John McMurray. Endpoints in Heart Failure Drug Development: History and Future. JACC. Heart failure. 2020 Jun;8(6):429-440

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PMID: 32278679

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