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Published on: July 12, 2024
Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials: A Call to Action From
Ersilia M DeFilippis1, Melvin Echols2, Philip B Adamson3
1Division of Cardiology, Columbia University Irving Medical Center, New York, New York.
Insights
Black and Hispanic individuals are underrepresented in heart failure (HF) clinical trials. Strategies exist to improve diverse enrollment, enhancing trial generalizability and clinical practice for all patients.
Area of Science:
- Cardiology
- Clinical Trials
- Health Equity
Background:
- Heart failure (HF) disproportionately affects Black and Hispanic individuals, yet they are underrepresented in clinical trials.
- This underrepresentation limits the applicability of trial findings and can create hesitancy in clinical practice.
- Existing policies have not fully resolved enrollment gaps, with globalization and access barriers contributing.
Purpose of the Study:
- To highlight the persistent underrepresentation of minority groups in heart failure clinical trials.
- To identify barriers contributing to this enrollment gap.
- To propose strategies for enhancing diversity in clinical trial participation.
Main Methods:
- Review of current trends in HF clinical trial enrollment.
- Analysis of factors contributing to underrepresentation.
- Identification of successful recruitment and engagement strategies.
Main Results:
- Despite efforts, significant racial and ethnic disparities in HF trial enrollment persist.
- Globalization of trials and US-centric enrollment limitations are key drivers.
- Barriers include access to care, logistical challenges, restrictive criteria, and language requirements.
Conclusions:
- Improving diverse enrollment in HF trials is feasible and essential.
- Strategies include thoughtful study design, site selection, diverse research teams, broader eligibility, and community engagement.
- Achieving representative enrollment enhances the generalizability and clinical translation of HF research findings.
Importance:
Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups.
Observations:
Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at improving trial representation, gaps in trial enrollment proportionate to the racial and ethnic composition of the HF population have persisted. Increasing trial globalization with limited US enrollment is a major driver of these patterns. Additional barriers to representative enrollment include inequities in care access, logistical issues in participation, restrictive enrollment criteria, and English language requirements.
Conclusions And Relevance:
Strategies for improving diverse trial enrollment include methodical study design and site selection, diversification of research leadership and staff, broadening of eligibility criteria, community and patient engagement, and broad stakeholder commitment. In contemporary HF trials, diverse trial enrollment is not only feasible but can be efficiently achieved to improve the generalizability and translation of trial knowledge to clinical practice.
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