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American Heart Association

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Final ID: MP2242

Disparities in Demographic Representation in Heart Failure Clinical Trials: A Systemic Analysis of Enrollment Patterns and Their Impact on Health Equity

Abstract Body (Do not enter title and authors here): Introduction
Heart failure with reduced ejection fraction (HFrEF) remains a leading cause of morbidity, mortality, and healthcare expenditures in the U.S. Despite its disproportionate burden on certain racial, ethnic, and socioeconomic groups, clinical trials often fail to reflect this demographic imbalance. This lack of representation compromises trial validity, contributing to healthcare disparities and increasing costs. Accurate demographic representation in clinical trials is essential for improving outcomes and reducing inequities.

Hypothesis
We hypothesize that there is a significant mismatch between the demographic composition of patients diagnosed with HFrEF and those enrolled in U.S.-based clinical trials, contributing to clinical disparities and elevated healthcare costs.

Methods
We performed a systematic analysis using data from ClinicalTrials.gov, including heart failure clinical trials with over 2.95 million participants. Demographic distributions by race, ethnicity, and gender were examined. To assess inclusivity, we calculated Enrollment Fractions (EF), the ratio of trial enrollees to the estimated U.S. disease prevalence in each demographic group. Statistical analysis was conducted using Python, with a significance threshold of p < 0.001.

Results
A total of 161 clinical trials, comprising 2.95 million participants, were analyzed. Of these, 758,721 (25.7%) were male and 1,008,409 (34.2%) were female. Racial distribution was skewed, with 45.7% Caucasian, 4.8% African American, and 0.7% Latino participants. Enrollment fractions for these groups were 4.12 for Caucasians, 0.21 for African Americans, and 0.04 for Latinos. Enrollment fractions for men and women were 1.37 and 0.72, respectively. Statistical analysis revealed significant disparities across racial and gender groups (p < 0.001).

Conclusion
Heart failure clinical trials show substantial demographic imbalances, with African American and Latino populations severely underrepresented. Men are enrolled at twice the rate of women, and Caucasians are represented 20 times more than African Americans and 100 times more than Latinos. These disparities emphasize the need for targeted recruitment strategies and policy reforms to ensure equitable representation. Addressing these inequities could help reduce healthcare disparities and the economic burden on underserved populations, ultimately advancing health equity and improving outcomes across diverse groups.
  • Obeng, Samed  ( Morehouse School of Medicine , East Point , Georgia , United States )
  • Amadi, Chima  ( Morehouse School of Medicine , East Point , Georgia , United States )
  • Ford, Dimitri  ( Morehouse School Of Medicine , Smyrna , Georgia , United States )
  • Saint Julien, Berlandson  ( Morehouse School of Medicine , East Point , Georgia , United States )
  • Opare-addo, Michael S. N.  ( Morehouse School of Medicine , East Point , Georgia , United States )
  • Chandora, Akshay  ( Morehouse School of Medicine , East Point , Georgia , United States )
  • Azees, Ridwan  ( Morehouse School of Medicine , Oklahoma City , Georgia , United States )
  • Author Disclosures:
    Samed Obeng: DO NOT have relevant financial relationships | chima amadi: DO NOT have relevant financial relationships | Dimitri Ford: DO NOT have relevant financial relationships | Berlandson Saint Julien: No Answer | Michael S. N. Opare-Addo: DO NOT have relevant financial relationships | Akshay Chandora: DO NOT have relevant financial relationships | Ridwan Azees: DO NOT have relevant financial relationships
Meeting Info:

Scientific Sessions 2025

2025

New Orleans, Louisiana

Session Info:

Social Determinants and Disparities: How Social Factors Shape Cardiovascular Outcomes

Monday, 11/10/2025 , 09:15AM - 10:15AM

Moderated Digital Poster Session

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