Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator (OPT-BB WOMEN)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiomyopathies
• Intervention / Treatment: Device: Heart Rate Monitor Enhanced Treatment Optimization

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Osz; Phone Number: 412-968-3333; Email: mosz@zoll.com
• Study Contact Backup: Name: Tara Roberts; Phone Number: 412-968-3333; Email: tara.roberts@zoll.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • TriHealth Hatton Research Institute
      • Contact: Kesari, MD
  • Texas
    • Kingwood, Texas, United States, 77339
      • Terminated
      • Texas Cardiology Associates of Houston
    • McKinney, Texas, United States, 75020
      • Recruiting
      • Cardiovoyage
      • Contact: Abo-Auda, MD
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Terminated
      • CAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heart Rate Monitor Enhanced Treatment Optimization; Subjects will wear an FDA-approved WCD with a 3 month follow-up period. Heart rate (HR) will be continuously monitored by the WCD.	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.; Other Names: LifeVest Wearable Cardioverter Defibrillator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Principal Investigator: Valentina Kutyifa, MD PHD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 90D0229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes