Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
NCT ID: NCT04504188
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2021-03-08
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
TREATMENT
NONE
Study Groups
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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.
Heart 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.
Interventions
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Heart 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
-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
* 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.
-Patients ending WCD use within the first two weeks of use.
18 Years
FEMALE
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Valentina Kutyifa, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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TriHealth Hatton Research Institute
Cincinnati, Ohio, United States
Texas Cardiology Associates of Houston
Kingwood, Texas, United States
CardioVoyage
McKinney, Texas, United States
CAMC
Charleston, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Kesari, MD
Role: primary
Abo-Auda, MD
Role: primary
Other Identifiers
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90D0229
Identifier Type: -
Identifier Source: org_study_id
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