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Optimizing Beta Blocker Dosage in Women Using the Wearable Cardioverter Defibrillator

This study is looking at how to best adjust medications like beta blockers and ivabradine in women who have heart muscle disease (cardiomyopathy) or heart failure and are wearing a wearable cardioverter defibrillator (WCD). The WCD continuously monitors your heart rate. Every two weeks, your healthcare provider will receive a report of your heart rate trends, and an alert if your heart rate is too high for three days in a row. This information helps your doctor adjust your medication to achieve a target average nighttime heart rate below 70 beats per minute. The study aims to see how well this approach works compared to past results. You may be eligible if you are an adult woman (18 years or older) with newly diagnosed cardiomyopathy and a low ejection fraction (EF ≤ 35%), and have been prescribed a WCD for about 90 days.

Study design
This is an interventional study with a planned enrollment of 300 female participants. It is a pilot study comparing a new approach to a historical control.
What's involved
You would wear an FDA-approved wearable cardioverter defibrillator (WCD) for approximately 3 months. Your heart rate will be continuously monitored by the WCD.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 3-month follow-up period, with heart rate control measured at 90 days.

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NCT04504188

Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator

UNKNOWN
NAAges 18+InterventionalTreatment
Zoll Medical Corporation
~300 participants
Updated 2024-07-24 on ClinicalTrials.gov
What's tested:Heart Rate Monitor Enhanced Treatment Optimization

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart Rate Control
Measured over 90 days

Conditions

Cardiomyopathies
Heart Failure

Explore related trials

CardiomyopathyHeart Failure

Where it's being run

4 sites across 3 states
Texas2
Ohio1
West Virginia1

Study leadership

  • Valentina Kutyifa, MD PHD · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Mike Osz
[email protected]
412-968-3333
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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.
Patients ending WCD use within the first two weeks of use.

What this trial measures

  • Heart Rate Control90 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.