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

Heart Failure Clinical Trial

— OPT-BB WOMEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04504188
• Other study ID #: 90D0229
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Zoll Medical Corporation
• Contact: Mike Osz
• Phone: 412-968-3333
• Email: mosz[@]zoll.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	CAMC	Charleston	West Virginia
United States	Texas Cardiology Associates of Houston	Kingwood	Texas
United States	CardioVoyage	McKinney	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Control	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.	90 days
Secondary	Heart Rate Control in Ischemic vs. Non-ischemic Patients	To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients	90 days
Secondary	Change in Average Nighttime Resting Heart Rate	Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.	90 days
Secondary	Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	To observe changes in quality of life over the course of WCD use using the KCCQ-12 Questionnaire. Higher scores on the KCCQ reflect better health status (range 0-100)	90 days
Secondary	Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)	To observe changes in quality of life over the course of WCD use using the EQ-5D-5L Questionnaire. Higher scores on the EQ-5D-5L reflect better health status (range 0-100)	90 days
Secondary	Changes in Functional Capacity	To observe changes in functional capacity as measured by average daily step count over the course of WCD use.	90 days