Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium
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William T Abraham1, Mitchell A Psotka2, Mona Fiuzat3
1Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
Insights
The Heart Failure Academic Research Consortium (HFC and ARC) established consensus recommendations for heart failure (HF) therapy evaluation. These guidelines aim to foster innovation in clinical trial design and endpoint definitions for HF treatments.
Area of Science:
- Cardiology
- Clinical Trials
- Translational Research
Background:
- Heart failure (HF) presents a significant global health challenge.
- Existing clinical trial methodologies require refinement for optimal evaluation of novel HF therapies.
- A collaborative approach involving diverse stakeholders is crucial for advancing HF research.
Purpose of the Study:
- To establish consensus definitions and key concepts for evaluating heart failure (HF) therapies.
- To provide recommendations for optimal medical and device background therapy in HF clinical trials.
- To stimulate innovation in the design and execution of HF clinical trials.
Main Methods:
- Convening a series of expert panel meetings involving key opinion leaders, patient representatives, and regulatory and industry members.
- Facilitating discussions on critical aspects of HF clinical trial design, including background therapy, statistical concepts, and endpoint selection.
- Synthesizing expert discussions into consensus-based recommendations.
Main Results:
- Development of consensus recommendations for HF populations and endpoint definitions.
- Identification of key considerations for optimal medical and device background therapy.
- Establishment of foundational concepts for robust HF clinical trial design.
Conclusions:
- The established recommendations provide a framework for future HF clinical trial innovation.
- Standardized definitions and approaches are essential for advancing the evaluation of HF therapies.
- Continued collaboration is vital to address the complexities of heart failure research and treatment.
Abstract:
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and Academic Research Consortium (ARC), comprised of leading heart failure (HF) academic research investigators, patients, United States (US) Food and Drug Administration representatives, and industry members from the US and Europe. A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies including optimal medical and device background therapy, clinical trial design elements and statistical concepts, and study endpoints. This manuscript summarizes the expert panel discussions as consensus recommendations focused on populations and endpoint definitions; it is not exhaustive or restrictive, but designed to stimulate HF clinical trial innovation.