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Novel Endpoints for Heart Failure Clinical Trials
Carine E Hamo1, Mihai Gheorghiade2, Javed Butler3
1Department of Medicine, Division of Cardiology, Stony Brook University, T-16, Room 080, Stony Brook, NY, 11794, USA.
Current Heart Failure Reports
|June 26, 2017
Summary
New pharmacologic treatments are needed for heart failure with preserved ejection fraction. This review explores alternative clinical trial endpoints beyond mortality and hospitalization, focusing on patient-centered outcomes like functional status and quality of life.
Area of Science:
- Cardiology
- Clinical Pharmacology
- Translational Medicine
Background:
- Heart failure prevalence is increasing, necessitating novel pharmacologic treatments.
- Effective therapies exist for heart failure with reduced ejection fraction, but not for preserved ejection fraction.
- Current treatment strategies for heart failure with preserved ejection fraction are limited.
Purpose of the Study:
- To review the potential utility of alternative clinical trial endpoints in heart failure drug development.
- To explore patient-centered outcomes as alternatives to traditional endpoints.
- To assess the incorporation of functional status and quality of life measures in clinical trials.
Main Methods:
- Literature review of current research on heart failure clinical trial endpoints.
- Analysis of the role of functional status and quality of life in drug development.
- Discussion of objective and subjective parameters for outcome measurement.
Main Results:
- There is growing interest in using alternative endpoints for heart failure drug development.
- Patient-centered outcomes like functional status and quality of life are attractive alternatives.
- Objective and subjective measures are preferred for assessing patient well-being.
Conclusions:
- Alternative endpoints to mortality and hospitalization are crucial for heart failure research.
- Incorporating patient-centered outcomes can better reflect treatment benefits.
- Further elucidation is needed on how to best integrate these alternative endpoints into clinical trial designs.
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