The first patient has been enrolled in Biotronik’s BIOWOMEN clinical study. BIOWOMEN will investigate cardiac resynchronisation therapy (CRT) response in women and men to evaluate if women respond better to treatment. It is the first study of its size to investigate the topic, addressing the urgent medical need for global, gender-specific clinical trials of heart failure patients.
“I am very excited to begin this ground-breaking trial,” says coordinating clinical investigator María José Sancho-Tello, Hospital Universitario La Fe, Valencia, Spain. “Clinical factors linked to CRT response seem to be more present in women when compared to men, but this has not yet been proven. With the proper patient selection, we want to discover if women do indeed respond better to CRT.”
In order to examine the interrelationship between gender, baseline clinical factors and CRT response, BIOWOMEN will enrol an even ratio of 247 patients of each sex in 25 centres in nine countries worldwide. Enrolment will take place over two years. There will be a one year follow-up, with results expected in 2018. The primary endpoint is response to CRT by measuring the left ventricular ejection fraction. Important secondary endpoints are baseline clinical factors, their relation to response, and QRS-complex related to CRT response.
Usually women are underrepresented in CRT and heart failure trials, constituting only 25–30% of patients enrolled. Nevertheless, relevant CRT trials such as MADIT CRT and CARE-HF have shown that clinical factors favouring CRT response are more present in women than in men, such as non-ischaemic cardiomyopathy, hypertension, diabetes and intra-ventricular dyssynchrony.
The current disproportion of female patients in CRT and heart failure trials is the result of a combination of factors. Co-coordinating clinical investigator of BIOWOMEN, Lieselot van Erven, LUMC, Leiden, the Netherlands, explains: “Women with heart failure also tend to have more atypical symptoms when compared to men, such as acute ischaemia. This leads to delayed diagnosis and delayed opportunities for CRT in general.” van Erven went on to say that confirming the effectiveness of CRT in women is of great importance for the female heart failure population and will give physicians more insight in the selection criteria. “This study could contribute to daily clinical decision-making,” she added.