A recent study revealed that recruiting more women into clinical trials for cardiac devices can offer more accurate and enhanced results.
According to the trial published in eClinicalMedicine, implantable cardiac defibrillators (ICDs) in patients with non-ischemic cardiomyopathy, a weakening of the heart muscle more common among women.
For the study, researchers ensured nearly half the participants were female.
Results indicated that men were twice as likely as women to die or suffer life-threatening arrhythmias such as Ventricular tachycardia (VT), Supraventricular tachycardia (SVT), and more after getting ICDs.
Lead investigator of the University of Rochester Medical Center, Dr. Valentina Kutyifa stated, “This is the first study that had a large enough number of females enrolled to show this difference.”
Kutyifa continued, “We learned that patients with non-ischemic cardiomyopathy do well with these devices, but they still have a residual risk… and this risk is lower in females,”
“Our data will help clinicians identify patients at higher risk and potentially intensify their treatment.”
For enhanced representation, scientists adapted the study design, aligning visits with regular care.
“Clinical trials might be too much of a time demand… Females may not know about studies, and doctors and study staff may assume females are at low risk,” Kutyifa explained.
According to the study, up to 48% of participants were female, which is significantly higher in contrast to the earlier ICD trials.
Equal enrollment revealed key insights: within a year, 13% of men had fatal irregular heart rhythms versus 6% of women.
