Abstract Body (Do not enter title and authors here): Background: The prevalence of risk factors for heart failure and outcomes varies across racial and ethnic groups. Despite this variation, treatment guidelines for heart failure are standardized, potentially overlooking the unique needs and responses of minority populations. This study aims to critically assess the underrepresentation of racial and ethnic minority groups in major clinical trials that have significantly influenced the development of guideline-directed medical therapy for heart failure with reduced ejection fraction (HFrEF).

Methods: We searched CINAHL, Embase, MEDLINE, and PubMed for randomized controlled trials (RCTs) that demonstrated reduced mortality or hospitalization through interventions in patients with HFrEF. We then analyzed the racial and ethnic data of the trial participants and compared minority enrollment to the 2020 United States Census demographic estimates.

Results: We examined 30 trials conducted from 1987 to 2021. Thirty percent of the trials did not report racial/ethnic data. Among the remaining trials, 20 reported participation rates for non-Hispanic White (NHW) individuals, 14 reported Black participation, one reported Hispanic participation, and seven reported Asian participation rates. One trial reported participation rates for all four groups. When we analyzed the pooled participation among trials reporting race/ethnicity, most participants were non-Hispanic White (81.7%), followed by Asian (16.1%), Hispanic (6.0%), and Black (5.2%) (image). Trials primarily conducted in North America showed greater representation of racial/ethnic minorities. Compared participation rates with 2020 U.S. Census estimates showed that Black and Hispanic populations were underrepresented.

Conclusion: The underrepresentation of racial and ethnic minorities in pivotal HFrEF clinical trials, which have significantly contributed to the development of guideline-directed therapy, is a matter of great concern. This lack of diversity may exacerbate health disparities by not adequately addressing the unique clinical characteristics and responses to therapy. It is not enough to acknowledge this problem; all stakeholders involved in clinical research must make sustained and collective efforts to ensure the equitable inclusion and reporting of racial and ethnic groups in trials. Improving the enrollment of ethnic minorities requires a shared and committed investment from investigators, research coordinators, oversight committees, and funding sources.