Heart Failure Clinical Trial
— OPT-BB WOMENOfficial title:
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
NCT number | NCT04504188 |
Other study ID # | 90D0229 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2021 |
Est. completion date | December 2023 |
Verified date | July 2022 |
Source | Zoll Medical Corporation |
Contact | Mike Osz |
Phone | 412-968-3333 |
mosz[@]zoll.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. Exclusion Criteria for Continuation Phase: -Patients ending WCD use within the first two weeks of use. |
Country | Name | City | State |
---|---|---|---|
United States | CAMC | Charleston | West Virginia |
United States | Texas Cardiology Associates of Houston | Kingwood | Texas |
United States | CardioVoyage | McKinney | Texas |
Lead Sponsor | Collaborator |
---|---|
Zoll Medical Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart 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. | 90 days | |
Secondary | Heart Rate Control in Ischemic vs. Non-ischemic Patients | To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients | 90 days | |
Secondary | 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. | 90 days | |
Secondary | 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) | 90 days | |
Secondary | 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) | 90 days | |
Secondary | Changes in Functional Capacity | To observe changes in functional capacity as measured by average daily step count over the course of WCD use. | 90 days |
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