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Trial Testing Heart Device Outcomes by Gender

Heart check

(Gerd Altmann, Pixabay)

6 May 2019. A clinical trial is underway tracking patients with implanted heart devices for 3 years to find any differences in health outcomes between men and women. The study is sponsored by Biotronik, a maker of implanted heart devices in Berlin, Germany, but enrolling only participants in the U.S.

The trial aims to uncover real-world evidence of differences between men and women in health effects from implanted devices that monitor and correct serious heart rhythm problems. Despite heart disease being a leading cause of death among women, their representation in clinical trials is often well below their proportion in the population.

The company cites a study published in 2016 showing men are historically better represented than women in clinical trials, and guidance from the Food and Drug Administration in 2014 calling for adequate numbers of women enrolled in clinical trials of heart devices to evaluate any differences between sexes. Only about 25 percent of participants in cardiac device trials, says Biotronik, are women

The clinical trial, named Bio-Libra, is enrolling up to 1,000 participants diagnosed with non-ischemic cardiomyopathy, or heart disease caused by factors other than coronary artery disease, also known as hardening of the arteries from the buildup of cholesterol. Individuals in the trial will also be those recommended for implanted heart devices to prevent sudden cardiac death.

And the study team aims to have women represent at least 40 percent of total participants, all of whom will be recipients of an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator device. Valentina Kutyifa, professor of cardiology at University of Rochester in New York and project leader, says in a Biotronik statement that, “The study will emphasize enrollment of women to fill the gap that currently exists in our knowledge of ICD effectiveness between sexes.”

An implantable cardioverter defibrillator, or ICD, keeps track of a person’s heart rate and if abnormal or rapid heart beats are detected, the device sends an electric pulse to re-regulate the individual’s heart rate. Newer devices also act as a pacemaker to keep abnormally slow heart rates in rhythm. A cardiac resynchronization therapy defibrillator, or CRT-D, is a similar device that re-synchronizes heart beats in left and right heart chambers. Biotronik makes both of these devices and will include newer models as options for patients.

The Bio-Libra trial is following participants for 3 years, looking primarily at events related to rapid or irregular heart rates, as well as deaths from any cause, with differences in these measures noted between genders and types of devices. The study team is likewise keeping track of several related measures, such as rates of heart disease events and those that lead to death, as well as medication use for heart disease and diabetes, inappropriate ICD therapy, partial shock-only device responses, and any complications from the devices, all also evaluated by gender and type of device.

Data on these outcomes from the trial are expected to better guide the choice of future therapies for women and men. The researchers also expect the results will help increase awareness of heart disease, which claims more lives among women than breast cancer.

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