Participation of Women in Cardiovascular Trials From 2017 to 2023

Cardiovascular (CV) disease is the leading cause of death globally for both men and women, yet women remain historically underrepresented in CV clinical trials, despite facing a disproportionately high burden of morbidity and mortality in many forms of CV disease. To determine the representation of women across a broad range of CV trials. The participation of women in CV trials registered on ClinicalTrials.gov from 2017 to 2023 was systematically determined through the extraction of publicly available information. Data were extracted to identify the country of study, disease type, trial size, clinical intervention, and age of the participants. The proportion of women and the ratio of number of female to male participants (F:M ratio) were calculated for each trial. The women's participation:prevalence ratio (PPR) was estimated for each trial based on the relative prevalence of the disease by sex in the specified region. A total of 1079 registered CV trials were identified, including 1 396 104 participants, of whom 571 641 (41.0%) were women. The F:M ratio was significantly lower for studies on arrhythmia (median IQR, 0.5), coronary heart disease (median IQR, 0.39 0.33-0.70), acute coronary syndrome (median IQR, 0.32 0.24-0.51), and heart failure (median IQR, 0.51 0.32-0.87) but higher for obesity (median IQR, 1.44 1.08-4.50) and pulmonary hypertension (median IQR, 2.86 1.50-3.97) trials. The F:M ratio was higher for trials on lifestyle interventions (median IQR, 1.51 0.77-3.24) than for drug trials. PPRs were low for clinical trials on coronary heart disease (median IQR, 0.66 0.50-0.86), acute coronary syndrome (median IQR, 0.79 0.51-0.87), and stroke (median IQR, 0.74 0.61-0.95). Representation of women in CV trials varied by disease state, region, intervention, and sponsor type. These findings highlight both progress and persistent challenges in representation of women within CV trials. These gaps not only limit the generalizability of trial outcomes but also perpetuate inequities in evidence-based care for women with CV conditions.