Increasing Female Participation in Cardiac Device Trials Enhances Outcomes for All Patients

Recent research highlights the importance of including more women in clinical trials for cardiac devices, revealing that such representation benefits the entire patient population. A notable study published in eClinicalMedicine examined how well implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) perform in treating non-ischemic cardiomyopathy, a condition more prevalent among women. The study achieved an unprecedented enrollment of nearly 48% female participants, providing valuable insights into sex-specific outcomes.

The interim results showed that men were twice as likely as women to experience life-threatening arrhythmias or death within one year of device implantation. Specifically, 13% of males faced serious complications compared to only 6% of females, indicating a 52% lower risk among women. These findings underscore that women with non-ischemic cardiomyopathy tend to respond better to these devices, though they still face residual risks that clinicians can better address with this data.

Led by Dr. Valentina Kutyifa from the University of Rochester Medical Center, the study involved 1,000 patients receiving ICDs or CRT-Ds. The research not only showed improved outcomes for women but also emphasized the importance of balancing trial demographics to reflect real-world populations, ultimately enhancing the effectiveness of treatment strategies.

Historically, women have been underrepresented in cardiac device trials, often comprising only 15-29% of participants. This underrepresentation might have led to a lack of gender-specific data, affecting treatment decisions. Recognizing these gaps, researchers like Kutyifa and Dr. Jeanne Poole designed the BIO-LIBRA study to actively increase female enrollment. They implemented strategies such as synchronizing study visits with routine care, utilizing remote monitoring, and broadening inclusion criteria—all aimed at reducing barriers like time constraints and caregiver responsibilities often faced by women.

These efforts proved successful, with the study exceeding its goal of 40% female participation. The inclusive approach also enrolled higher proportions of other underrepresented groups, reinforcing the value of demographic diversity in clinical research.

The study’s results advocate for the necessity of increasing female participation in medical research, illustrating that diverse data sets lead to more accurate, personalized care. As Dr. Kutyifa states, "Enrolling participants that mirror the actual patient population benefits everyone, not just those traditionally left out of studies."

For further details, the full study is available in eClinicalMedicine (2025): https://dx.doi.org/10.1016/j.eclinm.2025.103337. This research underscores the critical need for balanced representation in clinical trials to improve health outcomes for all genders and advance precision medicine.

Source: https://medicalxpress.com/news/2025-08-females-cardiac-device-trials-benefit.html