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Published on: June 10, 2025
Representation matters: a call for inclusivity and equity in heart failure clinical trials
Nosheen Reza1, Aditi Nayak2, Sabra C Lewsey3
1Division of Cardiovascular Medicine, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, 11 South Tower, Room 11-145, 3400 Civic Center Boulevard, Philadelphia, PA 19104, USA.
Insights
Heart failure with reduced ejection fraction (HFrEF) trials often exclude diverse populations, leading to treatment disparities. Future research must prioritize inclusivity for equitable heart failure care.
Area of Science:
- Cardiology
- Clinical Trials
- Health Equity
Background:
- Heart failure with reduced ejection fraction (HFrEF) is a significant global health burden.
- Approximately 50% of heart failure patients have HFrEF.
- Existing clinical trials frequently underrepresent diverse populations.
Purpose of the Study:
- To advocate for the inclusion of diverse populations in HFrEF clinical trials.
- To identify barriers hindering representation in HFrEF research.
- To propose strategies for enhancing inclusivity in future HFrEF studies.
Main Methods:
- Review of contemporary HFrEF clinical trial enrollment data.
- Analysis of disparities in HFrEF treatment access and outcomes.
- Identification of barriers to diverse participant recruitment.
- Development of recommendations for inclusive trial design.
Main Results:
- Clinical trials for HFrEF underrepresent minoritized sex, gender, race, ethnicity, and socioeconomic groups.
- Significant disparities in HFrEF treatment access and outcomes exist across these populations.
- Barriers to adequate representation were identified.
Conclusions:
- Diverse populations are underrepresented in HFrEF clinical trials, contributing to health disparities.
- Addressing these disparities requires a concerted effort to broaden inclusivity in research.
- Implementing proposed strategies can improve representation and lead to more equitable HFrEF care.
Abstract:
The burden of heart failure remains substantial worldwide, and heart failure with reduced ejection fraction (HFrEF) affects approximately half of this population. Despite this global prevalence of HFrEF, the majority of contemporary clinical trials in HFrEF have underenrolled individuals from minoritized sex, gender, race, ethnicity, and socioeconomic groups. Moreover, significant disparities in access to HFrEF treatment and outcomes exist across these same strata. We provide a call to action for the inclusion of diverse populations in HFrEF clinical trials; catalogue several barriers to adequate representation in HFrEF clinical trials; and propose strategies to broaden inclusivity in future HFrEF trials.
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