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

Area of Science:

• Cardiology
• Digital Health
• Pharmacology

Background:

• Heart failure (HF) management guidelines emphasize beta-blocker (BB) titration for improved survival.
• Women with HF are often undertreated with BBs, highlighting a gap in optimized therapy.
• No studies have explored remote heart rate (HR) monitoring for optimizing BB treatment in women.

Purpose of the Study:

• To evaluate the utility of HR data and alerts from a wearable cardioverter-defibrillator (WCD) for optimizing BB/ivabradine dosage.
• To assess remote HR monitoring's impact on medication titration in women with newly diagnosed cardiomyopathy and reduced ejection fraction.

Main Methods:

• Prospective, multi-center pilot study enrolling up to 300 women prescribed a WCD.
• 3-month study phase with biweekly HR trend reports and HR alerts to guide BB/ivabradine titration.
• Analysis of HR data, including median nighttime HR, and quality of life scores.

Main Results:

• The study is powered to detect improved HR control in 70% of subjects compared to a historical cohort (56%).
• Secondary endpoints include nighttime median HR and HR control alerts.
• Tertiary endpoints assess median nighttime HR, quality of life, and physical activity.

Conclusions:

• This female-only study will offer clinically relevant insights into remote HR monitoring for optimizing HF treatment post-discharge.
• Findings will inform strategies for improving BB/ivabradine dosage in women with HF.