One-year results showed that 13% of males experienced life-threatening arrhythmias or death, compared to only 6% of females, indicating a 52% lower risk for women.

These findings highlight that more representative clinical trials not only improve demographic balance but also uncover critical differences in outcomes based on sex.

Ultimately, adopting more inclusive trial designs can lead to more personalized and effective patient care across diverse populations.

The study, known as BIO-LIBRA, focused on the performance of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in patients with non-ischemic cardiomyopathy, a condition more prevalent among females.

A recent study significantly increased female participation in cardiac device trials, enrolling nearly 48% of participants, a stark contrast to previous trials that typically included only 15-29% females.

Researchers overcame barriers to female enrollment by aligning study visits with regular care, utilizing remote monitoring, and broadening inclusion criteria to include older or comorbid women.

This more inclusive approach revealed important sex-specific differences in patient outcomes, emphasizing that females with non-ischemic cardiomyopathy have a lower residual risk of adverse events.

The data from this study can help clinicians tailor treatments, especially since females with non-ischemic cardiomyopathy tend to have a lower residual risk of adverse events.

The improved understanding of sex-specific outcomes underscores the importance of including more women in clinical research to guide better care for all patients.

Overall, this study demonstrates that increasing female participation in cardiac device trials enhances our understanding of patient outcomes and supports more equitable healthcare.