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More Women In Study Reveals Heart Risk For Men

By Dennis Thompson HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 27, 2025.

WEDNESDAY, Aug. 27, 2025 — Recruiting more women to clinical trials for heart devices can improve care for all cardiac patients, a new study argues.

A trial investigating the effectiveness of implantable cardiac defibrillators (ICDs) wound up revealing vital information because researchers made sure nearly half the study participants were female, researchers reported Aug. 25 in the journal eClinicalMedicine.

The trial involved patients with non-ischemic cardiomyopathy, a weakening of the heart muscle that is more common among women, researchers said.

Results showed that men with the condition were twice as likely as women to die or experience life-threatening heart rhythm problems when treated using the implants.

“This is the first study that had a large enough number of females enrolled to show this difference,” lead investigator Dr. Valentina Kutyifa, a professor of cardiology heart research at the University of Rochester Medical Center, said in a news release.

“We learned that patients with non-ischemic cardiomyopathy do well with these devices, but they still have a residual risk of developing life-threatening ventricular arrhythmias or dying, and this risk is lower in females,” Kutyifa said. “Our data will help clinicians identify patients at higher risk and potentially intensify their treatment.”

ICDs are implants that monitor a person’s heartbeat and provide electric shocks to correct abnormal heart rhythms or restart a heart in cardiac arrest.

For this study, researchers recruited 1,000 people with non-ischemic cardiomyopathy to see how well common ICDs would perform in treating the disease. Non-ischemic means that blocked arteries are not contributing to the weakening of heart muscle

The researchers insisted that the study recruit enough women to reflect the real world, in which females make up roughly half of the population.

The original trials testing ICDs focused on a type of heart problem more common in males, ischemic cardiomyopathy, researchers noted. In those trials, 15% to 29% of participants were female.

To enroll more women, researchers had to address multiple barriers that prevent females from participating in studies.

“Clinical trials might be too much of a time demand, too much to juggle with family, because females are still more likely to be caregivers,” Kutyifa said. “Females may not know about studies, and doctors and study staff may assume females are at low risk or ineligible for a study.”

Researchers designed the study so research visits would coincide with participant’s regular health care appointments. They also used remote monitoring to reduce the time demands of the study.

As a result, the research team blew past its original goal of recruiting 40% females, winding up with women representing nearly 48% of the total study population.

Equal representation revealed important data. About 13% of men in the study had experienced a life-threatening heart rhythm abnormality within a year of receiving their ICD, compared with 6% of women.

The trial will continue to monitor participants for at least three years, researchers said.

“As we’ve shown in this study, enrolling participants that better reflect the actual patient population benefits everyone, not just those who have been left out in the past,” Kutyifa said.

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.

Posted August 2025

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