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J Card Fail. 2018 Sep 11. pii: S1071-9164(18)30960-6. doi: 10.1016/j.cardfail.2018.08.007. [Epub ahead of print]

A Critical Appraisal of Short-Term End Points in Acute Heart Failure Clinical Trials.

Author information

1
Division of Cardiology, Johns Hopkins University, Baltimore, Maryland, United States.
2
Cardiology Division, Inova Heart and Vascular Institute, Falls Church, Virginia, United States.
3
Division of Cardiology, University of Brescia and Civil Hospital, Brescia, Italy.
4
Division of Cardiology and Cardiovascular Center, Tufts Medical Center, Boston, Massachusetts, United States.
5
Center for Cardiovascular Innovation, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
6
Cardiology Division, Stony Brook University, Stony Brook, New York, United States. Electronic address: javed.butler@stonybrookmedicine.edu.

Abstract

The prevalence of heart failure continues to grow, and this is accompanied by an increase in hospitalization for acute heart failure. Hospitalization for heart failure results in a trajectory shift of the syndrome and is associated with worsening outcomes, increased mortality risk, and high costs. Numerous clinical trials over the past 2 decades have had limited success, with no single agent shown to improve mortality risk. The lack of success is multifactorial and in part related to inadequate targets and end points selected for intervention, underscoring the need to better understand and define the pathophysiology of acute heart failure. To better inform future drug development, this review critically explores the short-term end points and outcomes that previous phase III acute heart failure trials have examined.

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