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

Background: Heart failure (HF) guidelines recommend titration of beta-blockers (BBs) to improve survival; however, women are less optimized with BBs, and there are no studies that have assessed the utility of remote heart rate (HR) monitoring to optimize treatment. Objective: We aimed to assess the utility of HR data and HR alerts from the wearable cardioverter-defibrillator (WCD) to optimize BB/ivabradine dosage in women with newly diagnosed cardiomyopathy with reduced ejection fraction, prescribed the WCD as standard of care. Methods: The Optimizing Beta-Blocker Dosage in Women Using the Wearable Cardioverter Defibrillator study is a multi-center, prospective pilot study that will enroll up to 300 patients at 20 sites in Europe and the United States, 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 trend reports and HR alerts (first month: >90 bpm, second month: >80 bpm, third month: >70 bpm) to the enrolling sites, to facilitate titration of BBs and ivabradine. A total of 95 subjects with a full dataset will provide sufficient power to detect an improvement of effective HR control in 70% of the subjects (as compared to 56% in a historical cohort). Secondary end points include HR reported as nighttime median value and HR control alerts. Tertiary end points include median nighttime HR, quality of life scores, and physical activity. Conclusion: This female-only study will provide clinically actionable information on the impact of remote monitoring of HR during the early post-discharge period in women with HF who achieve adequate BB/ivabradine dosage.