Clinical trial NCT04504188: Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Official title: Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiomyopathies
Heart Failure
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

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.

Primary outcomes:
measure: Heart Rate Control
timeFrame: 90 days
Secondary outcomes:
measure: Heart Rate Control in Ischemic vs. Non-ischemic Patients
timeFrame: 90 days
measure: Change in Average Nighttime Resting Heart Rate
timeFrame: 90 days
measure: Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 90 days
measure: Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
timeFrame: 90 days
measure: Changes in Functional Capacity
timeFrame: 90 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth Hatton Research Institute
state: Ohio
city: Kingwood
country: United States
facility: Texas Cardiology Associates of Houston
state: Texas
city: McKinney
country: United States
facility: CardioVoyage
state: Texas
city: Charleston
country: United States
facility: CAMC
state: West Virginia
Study officials:
affiliation: University of Rochester
name: Valentina Kutyifa, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: