RecruitingNot ApplicableNCT04504188

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

Sponsor

Zoll Medical Corporation

Enrollment

300 participants

Start Date

Mar 8, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiomyopathies

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria9

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.

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.