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Published on: June 10, 2025
Redefining the role of biomarkers in heart failure trials: expert consensus document
Frank Kramer1, Hani N Sabbah2, James J Januzzi3
1BAYER AG, Experimental Medicine Cardiovascular/Hematology, Aprather Weg 18a, 42133, Wuppertal, Germany. frank.kramer@bayer.com.
Insights
Novel treatments for heart failure are in development. This review examines molecular, imaging, and digital biomarkers, discussing their capabilities and limitations in heart failure drug development and clinical management.
Area of Science:
- Cardiovascular Medicine
- Biomarker Research
- Drug Development
Background:
- Heart failure (HF) is a significant and growing cardiovascular disease with major health and societal impacts.
- There is a high unmet need for effective novel treatments for heart failure.
- Biomarkers are crucial for patient stratification and monitoring in clinical trials and patient management.
Purpose of the Study:
- To provide an overview of the role of biomarkers in heart failure drug development.
- To discuss the capabilities and limitations of various biomarker types in this context.
Main Methods:
- Review of available molecular biomarkers.
- Review of available imaging biomarkers.
- Review of available device-derived digital biomarkers.
Main Results:
- Biomarkers are essential tools in the development of new heart failure therapies.
- Different biomarker types offer unique advantages and face specific challenges.
- Understanding biomarker utility is key to successful drug development and clinical application.
Conclusions:
- Biomarkers are integral to advancing heart failure drug development.
- A comprehensive understanding of biomarker capabilities and limitations is necessary.
- Continued research into novel biomarkers will aid in addressing the unmet needs in heart failure treatment.
Abstract:
Heart failure is a growing cardiovascular disease with significant epidemiological, clinical, and societal implications and represents a high unmet need. Strong efforts are currently underway by academic and industrial researchers to develop novel treatments for heart failure. Biomarkers play an important role in patient selection and monitoring in drug trials and in clinical management. The present review gives an overview of the role of available molecular, imaging, and device-derived digital biomarkers in heart failure drug development and highlights capabilities and limitations of biomarker use in this context.
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