How the Clinical Trial Gender Gap Affects Women’s Heart Care

Women being underrepresented in cardiovascular clinical trials has led to a knowledge gap of sex-based differences in heart disease.

With most early studies focusing on men, treatments, and guidelines were developed without adequately understanding how heart disease affects women differently. Despite policy changes in the 1990s that mandated the inclusion of women in clinical trials, these disparities persist, limiting the generalizability of research findings and potentially leading to gaps in treatment outcomes for women. These research gaps continue to impact clinical care for women, as key differences in symptoms, disease progression, and treatment responses are still not fully understood.

Part 1 of this 2-part series focused on the gap between men and women in heart disease clinical trials; this part explores how it contributes to the care gap seen in practices.¹

How Does This Gap Affect Women’s Heart Health Care?

A review published in Cureus revealed 13 common themes in gender-based disparities in cardiovascular health, including disparities in treatment and secondary prevention, differing symptom presentation, delayed diagnosis or misdiagnosis in women, and more.²

Women often experience delays in presenting with heart disease and related cardiovascular events, leading to poorer outcomes. A study by Nguyen et al. included in the review identified that women—particularly those who are older and single—often delay seeking medical attention due to not wanting to trouble others, being alone at symptom onset, and having a previous myocardial infarction (MI) history.³ This contrasts with men, who delay for reasons such as low education and declining ambulance transport. In that study, the median pre-hospital delay for women ranged from 1.8 to 7.2 hours, compared with just 1.4 to 3.5 hours for men, with women being more likely to present later than men.

Women often receive suboptimal cardiovascular care compared with men | Image credit: lenets_tan – stock.adobe.com

The misconception that women exhibit the same cardiovascular disease symptoms as men contributes to misdiagnosis and delays.² According to the review, 75% of the included articles said gender-based presentation differences played a major role in gender-based disparities in heart health. Research shows that women often experience generalized chest pain or discomfort but also many non-chest pain symptoms such as nausea, fatigue, back pain, heart palpitations, and shortness of breath. Meanwhile, men typically report chest pain and diaphoresis—common symptoms of MI.⁴

On the other end, it’s important that clinicians and researchers stop having a male-centric idea of what heart disease symptoms are. Rather than saying women have an “atypical” presentation—which enforces the idea that men’s symptoms are more “typical” and what clinicians are looking for, referred to as the “male template”—there should instead be terms that recognize sex-specific differences and the significant overlap in symptoms between men and women.⁵

“This contributes to the notion of CVD being a man’s disease and leads to the misconceptions of signs and symptoms to monitor for, resulting in a lack of awareness/recognition of symptoms and therefore ultimately a delay in presentation,” the review authors said.²

Looking more into delayed care, another study in the review highlighted that women often receive suboptimal health care compared with men, especially after ST-segment elevation myocardial infarction (STEMI), with women having lower rates of thrombolysis and primary reperfusion therapy despite higher survival benefits from these treatments. Delays in seeking treatment result in women being in poorer conditions at presentation, often leading to exclusion from newer therapies. Other researchers confirmed these delays, noting women are slower to receive treatments that reduce the risk of recurrent cardiovascular events.

The review also highlighted significant disparities in post-MI treatments, with White and Black women 10% and 25% less likely than White men to undergo cardiac catheterization, respectively.

This gender inequality extends to lower rates of angiography and is partly due to a gender bias in CVD diagnosis and treatment, and the underrepresentation of women undergoing invasive procedures—despite their effectiveness—suggests a selection bias by clinicians.^6,7 These studies collectively underscore the pressing need for health care systems to address gender biases and ensure equitable treatment for women in cardiovascular care.

What Is Being Done to Bridge the Gap?

During an interview with The American Journal of Managed Care® (AJMC®), Kathryn Lindley, MD, FACC, associate professor of medicine and associate professor of obstetrics and gynecology at Vanderbilt University Medical Center, highlighted the multidisciplinary approach Vanderbilt's Women's Heart Center is taking to help bridge the gender gap in cardiovascular health care.⁸

Collaborative clinics bring specialists from different fields together to coordinate care for patients with complex needs, improving communication among providers. Remote monitoring and telehealth have also been implemented to help patients manage conditions like high blood pressure from home, reducing the need for in-person visits and easing barriers to care.

“Sometimes it's much easier to be able to just send in your blood pressure through an app or take a telehealth appointment from your kitchen, rather than trying to take a day off of work to come in to get your blood pressure checked or to see your doctor,” Lindley said. “So, just thinking about ways that we can really bring care to patients where they're at, rather than asking them to come to us.”

The center has also focused on advancing research by partnering with cardiology and OBGYN departments to study how heart disease develops in women. Efforts have been made to design clinical trials that accommodate women’s schedules, aiming to improve enrollment and representation. According to Lindley, these strategies have so far helped to streamline care, especially for postpartum health and hypertension.

“[The new approach] has definitely improved the ability for us to get information about people's blood pressure and treat them more consistently than if we used more traditional methods of health care delivery,” she added.

She also noted that Vanderbilt is preparing to launch a cardio-rheumatology clinic to address the heart risks associated with autoimmune disorders, which disproportionately affect women. Another planned initiative is a menopausal heart health clinic, which will offer cardiovascular screening and guidance on hormone therapy, focusing on improving health outcomes during and after menopause.

The Women’s Heart Center is part of a broader push to address cardiovascular disparities through collaborative efforts. The St. Louis Go Red for Women movement is chaired by Alaina Macia, MBA, president and CEO of MTM, Inc., and highlights the ongoing urgency of improving women’s heart health across the country.⁹ The initiative, which began more than 2 decades ago, aims to raise awareness and catalyze change in response to cardiovascular disease’s status as the leading cause of death among women, surpassing all cancers combined.

The campaign seeks to educate and empower women to take control of their heart health while providing credible, equitable health solutions. With nearly 45% of women over 20 living with some form of cardiovascular disease, programs like Go Red for Women continue to play a vital role in addressing this public health challenge, complementing local efforts like Vanderbilt’s multidisciplinary care model. Together, initiatives like these aim to reduce barriers to care and improve outcomes for women facing cardiovascular risks, but more efforts are needed nationwide.

References

1. Klein HE. Why are we still seeing gaps in women’s heart care? AJMC. October 15, 2024. Accessed October 15, 2024. https://www.ajmc.com/view/why-are-we-still-seeing-gaps-in-women-s-heart-care-
2. Bosomworth J, Khan Z. Analysis of gender-based inequality in cardiovascular health: an umbrella review. Cureus. 2023;15(8):e43482. doi:10.7759/cureus.43482
3. Nguyen HL, Saczynski JS, Gore JM, Goldberg RJ. Age and sex differences in duration of prehospital delay in patients with acute myocardial infarction: a systematic review. Circ Cardiovasc Qual Outcomes. 2010;3(1):82-92. doi:10.1161/CIRCOUTCOMES.109.884361
4. van Oosterhout REM, de Boer AR, Maas AHEM, Rutten FH, Bots ML, Peters SAE. Sex differences in symptom presentation in acute coronary syndromes: a systematic review and meta-analysis. J Am Heart Assoc. 2020;9(9):e014733. doi:10.1161/JAHA.119.014733
5. Hamill S, Ingram N. Gender disparities: assessment and treatment of coronary heart disease. Br J Card Nurs. Published online October 6, 2015. doi:10.12968/bjca.2015.10.10.494
6. Mannem S, Rattanawong P, Riangwiwat T, et al. Sex difference and outcome after percutaneous intervention in patients with chronic total occlusion: a systematic review and meta-analysis. Cardiovasc Revasc Med. 2020;21(1):25-31. doi:10.1016/j.carrev.2019.03.003
7. Lewey J, Shrank WH, Bowry AD, Kilabuk E, Brennan TA, Choudhry NK. Gender and racial disparities in adherence to statin therapy: a meta-analysis. Am Heart J. 2013;165(5):665-678.e1. doi:10.1016/j.ahj.2013.02.011
8. Klein HE. How Vanderbilt's Women's Heart Center is bridging the gender gap in heart health. AJMC. July 5, 2024. Accessed October 15, 2024. https://www.ajmc.com/view/how-vanderbilt-s-women-s-heart-center-is-bridging-the-gender-gap-in-heart-health
9. MTM, Inc. president & CEO leads local movement to improve women’s heart health. American Heart Association. News release. October 09, 2024. Accessed October 15, 2024. https://newsroom.heart.org/local-news/mtm-inc-president-ceo-leads-local-movement-to-improve-womens-heart-health