NCT04504188 Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
| NCT ID | NCT04504188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zoll Medical Corporation |
| Condition | Cardiomyopathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2024-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-03-08 with a primary completion date of 2024-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Valentina Kutyifa, MD PHD
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT04504188 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cardiomyopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04504188 currently recruiting?
Yes, NCT04504188 is actively recruiting participants. Contact the research team at mosz@zoll.com for enrollment information.
Where is the NCT04504188 trial being conducted?
This trial is being conducted at Cincinnati, United States, Kingwood, United States, McKinney, United States, Charleston, United States.
Who is sponsoring the NCT04504188 clinical trial?
NCT04504188 is sponsored by Zoll Medical Corporation. The principal investigator is Valentina Kutyifa, MD PHD at University of Rochester. The trial plans to enroll 300 participants.