Cardiology • Practice

Women’s Representation in Cardiovascular Trials: Trends and Disparities

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Article Impact Level: HIGH
Data Quality: STRONG
Summary of JAMA Network Open, 8(8), e2529104. https://doi.org/10.1001/jamanetworkopen.2025.29104
Dr. Frederick Berro Rivera et al.

Points

  • Women remain underrepresented in cardiovascular clinical trials, despite disproportionately high morbidity and mortality in many forms of cardiovascular disease.
  • A systematic review of 1079 cardiovascular trials from 2017 to 2023 found that women constituted 41.0% of the 1,396,104 participants.
  • Female representation was significantly lower in trials for arrhythmia, coronary heart disease, acute coronary syndrome, and heart failure.
  • Higher female participation was observed in studies on obesity, pulmonary hypertension, and lifestyle interventions.
  • Efforts are needed to implement inclusive trial designs and enhanced outreach strategies to bridge existing participation disparities.

Summary

A systematic review identified 1079 cardiovascular clinical trials registered from 2017 to 2023, encompassing 1,396,104 participants, with 571,641 (41.0%) women. The median female-to-male (F:M) ratios were notably lower for studies on arrhythmia (0.5), coronary heart disease (0.39; IQR, 0.33-0.70), acute coronary syndrome (0.32; IQR, 0.24-0.51), and heart failure (0.51; IQR, 0.32-0.87). Conversely, trials on obesity (1.44; IQR, 1.08-4.50) and pulmonary hypertension (2.86; IQR, 1.50-3.97) exhibited higher female representation. Lifestyle interventions also showed a higher F:M ratio (1.51; IQR, 0.77-3.24) compared to drug trials.

The women’s participation:prevalence ratios (PPRs) were low for coronary heart disease (0.66; IQR, 0.50-0.86), acute coronary syndrome (0.79; IQR, 0.51-0.87), and stroke (0.74; IQR, 0.61-0.95), indicating underrepresentation relative to disease prevalence. In contrast, obesity (1.44; IQR, 1.10-1.70) and pulmonary hypertension (1.30; IQR, 1.05-1.40) demonstrated higher PPRs. Trials sponsored by research institutions had a higher median PPR of women (1.12; IQR, 0.72-1.52) compared to industry-funded (0.74; IQR, 0.54-1.04) or government-funded trials (0.55; IQR, 0.15-0.95), with a statistically significant difference (P < .001).

While overall women’s participation showed no significant change from 2017 to 2024 (z=1.91; P=.06), heart failure trials demonstrated a significant increase in female participation during this period (z=1.99; P=.046). A significant upward trend in women’s participation was observed during the COVID-19 pandemic years (2019-2022) with a PPR of 0.98 (z=3.01; P=.003), largely attributed to increased participation in hypertension trials (PPR, 0.82; z=3.40; P=.001). US-based trials generally achieved higher PPRs (1.05; IQR, 0.63-1.47) compared to global (0.72; IQR, 0.54-1.01) or European (0.71; IQR, 0.53-0.98) studies.

Link to the article: https://medicalxpress.com/news/2025-09-women-common-cardiac-conditions.html 

References

Rivera, F. B., Magalong, J. V., Bantayan, N. R. B., Tesoro, N., Milan, M. J., Purewal, V., Pine, P. L. S., Tsai, C.-M., Navar, A. M., Mulvagh, S. L., Januzzi, J., Gibson, C. M., Lala-Trindade, A., Cheng, S., Lara-Breitinger, K., Guerrero, M., & Gulati, M. (2025). Participation of women in cardiovascular trials from 2017 to 2023: A systematic review. JAMA Network Open, 8(8), e2529104. https://doi.org/10.1001/jamanetworkopen.2025.29104

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