Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
- Conditions
- Heart FailureCardiomyopathies
- Interventions
- Device: Heart Rate Monitor Enhanced Treatment Optimization
- Registration Number
- NCT04504188
- Lead Sponsor
- Zoll Medical Corporation
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Heart Rate Monitor Enhanced Treatment Optimization Heart Rate Monitor Enhanced Treatment Optimization Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.
- Primary Outcome Measures
Name Time Method Heart Rate Control 90 days The primary objective of this study is to document the percentage achievement in effective HR control (average nighttime HR \< 70 bpm) during WCD use in female patients.
- Secondary Outcome Measures
Name Time Method Change in Average Nighttime Resting Heart Rate 90 days Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 90 days To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100)
Changes in Functional Capacity 90 days To observe changes in functional capacity as measured by average daily step count over the course of WCD use.
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L) 90 days To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100)
Heart Rate Control in Ischemic vs. Non-ischemic Patients 90 days To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
Trial Locations
- Locations (4)
Texas Cardiology Associates of Houston
🇺🇸Kingwood, Texas, United States
CardioVoyage
🇺🇸McKinney, Texas, United States
TriHealth Hatton Research Institute
🇺🇸Cincinnati, Ohio, United States
CAMC
🇺🇸Charleston, West Virginia, United States