Cardiomyopathies, Heart Failure
Conditions
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.
Interventions
DEVICEHeart Rate Monitor Enhanced Treatment Optimization
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.
Sponsors
Zoll Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Screening Phase: * Female patients with newly diagnosed (never hospitalized for HF in the last 30 days prior to enrollment) ischemic or non-ischemic cardiomyopathy and an EF ≤ 35% at the time of WCD prescription. * Patients prescribed the WCD for an intended 90 ± 14 days of use. * Patients have used the WCD for no more than 14 days from the day of consent. * Patients 18 years of age or older at the time of consent. Inclusion Criteria for Continuation Phase: -After the first 2 weeks of WCD wear, only actively wearing patients averaging at least 105 hours of WCD wear per week (or 15 hours/day) are eligible to continue.
Exclusion criteria
for Screening Phase: * Patients with a known contraindication or intolerance to beta-blocker therapy. * Patients with permanent atrial fibrillation. * Patients who have a pacemaker. * Patients with a current or prior implantable cardioverter defibrillator (ICD). * Patients who are self-reporting to be pregnant. * Patients with known congenital or inherited heart disease. * Patients participating in another interventional clinical trial. * Patients not expected to live longer than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 (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) |
| 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. |
Countries
United States
Contacts
Primary ContactMike Osz
Backup ContactTara Roberts
Outcome results
None listed