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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
TriHealth Hatton Research Institute
Cincinnati, Ohio, United States
RECRUITINGTexas Cardiology Associates of Houston
Kingwood, Texas, United States
TERMINATEDCardioVoyage
McKinney, Texas, United States
RECRUITINGHeart Rate Control
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.
Time frame: 90 days
Heart Rate Control in Ischemic vs. Non-ischemic Patients
To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
Time frame: 90 days
Change in Average Nighttime Resting Heart Rate
Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
Time frame: 90 days
Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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)
Time frame: 90 days
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
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)
Time frame: 90 days
Changes in Functional Capacity
To observe changes in functional capacity as measured by average daily step count over the course of WCD use.
Time frame: 90 days
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CAMC
Charleston, West Virginia, United States
TERMINATED