BIOWOMEN Study, v1.0, 03.Dec.2014
Research type
Research Study
Full title
BIOWOMEN Study (Clinical Investigation on differences in the magnitude of CRT response in WOmen versus MEN)
IRAS ID
171873
Contact name
Susan Ellery
Contact email
Sponsor organisation
CEM Biotronik
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 27 days
Research summary
Cardiac Resynchronization Therapy (CRT) is an accepted treatment for selected heart failure patients. In terms of subject numbers, women are poorly represented in previous studies involving CRT although existing data suggests that women may respond to CRT even more positively than men.
This is a prospective, non-randomized, international study to investigate gender differences in baseline characteristics and in the magnitudes of response to CRT. 247 men and 247 women, all requiring CRT, will be enrolled. All patients will receive appropriate, indicated therapy, which will include the implantation of an implantable device to provide CRT. Following their enrollment, implantation and hospital discharge, each subject will visit the clinic at 2, 6 and 12 months for routine follow-up and additional study-specific tests and measurements. The study specific assessments include echocardiography (an ultrasound scan of the heart), a 6 minute walking distance test and Quality of Life Questionnaire. These will all be performed at Enrollment, 6 months and 12 months. The main purpose of the study is to show that, on average, women have a better response to CRT than men. The key measurement for this in the study will be improvement in the patients' Left Ventricular Ejection Fraction (LVEF) which is one of the parameters measured by echocardiography. LVEF represents the effectiveness of the pumping action of the heart. The study will also investigate potential reasons for any gender difference in the responses to CRT, particularly looking for differences in baseline characteristics.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0622
Date of REC Opinion
10 Sep 2015
REC opinion
Further Information Favourable Opinion