Abstract 4370982: Disparities in Demographic Representation in Heart Failure Clinical Trials: A Systemic Analysis of Enrollment Patterns and Their Impact on Health Equity

Abstract

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.