OPTimizing Beta-Blocker Dosage in Women Using the Wearable Cardioverter-Defibrillator (OPT-BB Women): Study design

<h2>ABSTRACT</h2><h3>Background</h3> Heart failure (HF) guidelines recommend titration of beta-blockers to improve survival, however females are less optimized with beta-blockers, and no studies assessed the utility of remote heart rate (HR) monitoring to optimize treatment. <h3>Objective</h3> We aimed to assess the utility of HR data and HR alerts from the wearable cardioverter-defibrillator (WCD) to optimize beta-blocker (BB)/ivabradine dosage in females with newly diagnosed cardiomyopathy with reduced ejection fraction, prescribed the WCD as standard of care.. <h3>Methods</h3> The OPT-BB Women study is a multi-center, prospective pilot study to enroll up to 300 patients at 20 sites in Europe and U.S. with a 2-week run-in phase to assess WCD compliance and HR data completion. Those with at least 105 hours per week WCD wear will be advanced into the 3-month study. In the study phase, we will provide biweekly HR trends reports to the enrolling sites, and HR alerts (1^st month: >90 bpm, 2^nd month: >80 bpm, 3^rd month: >70 bpm) to facilitate titration of beta-blockers and ivabradine. A total of 95 subjects with full dataset will provide sufficient power to detect an improvement of effective heart rate control in 70% of the subjects (as compared to 56% in a historical cohort). Secondary endpoints include HR reported as nighttime median value and HR control alerts. Tertiary endpoints include median nighttime HR, quality of life scores, and physical activity. <h3>Conclusions</h3> This female-only study will provide clinically actionable information on the impact of remote monitoring of HR during the early post-discharge period in females with HF who achieve adequate BB/ivabradine dosage.