Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator — OPT-BB WOMEN  

Heart Failure Clinical Trial

Official title: Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

Status Recruiting

Clinical Trial Summary

The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.

Clinical Trial Description

The primary objective of this pilot study is to document the percentage achievement in effective HR control (average nighttime HR < 70 bpm) during WCD use in a cohort of female patients with cardiomyopathy in an outpatient setting using continuous heart rate (HR) trends data from the WCD to optimize BB/ivabradine dosage, as compared to a prior historical control.

Adult female patients (18 years or older) who are prescribed the wearable cardioverter defibrillator (WCD) for 3 months for ischemic or non-ischemic cardiomyopathy with a low ejection fraction.

Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.

Based on this information, clinicians should follow guideline-directed medical therapy (GDMT) to add or titrate medication accordingly. The goal of these changes will be to achieve the average nighttime HR to recommended guidelines (<70 bpm) by the end of WCD use. ;

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

• NCT number: NCT04504188
• Study type: Interventional
• Source: Zoll Medical Corporation
• Contact: Mike Osz
• Phone: 412-968-3333
• Email: mosz@zoll.com
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Completion date: December 2023