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

Primary Purpose

Cardiomyopathies, Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Rate Monitor Enhanced Treatment Optimization
Sponsored by
Zoll Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Texas Cardiology Associates of HoustonRecruiting
  • CardioVoyageRecruiting
  • CAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Rate Monitor Enhanced Treatment Optimization

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Heart Rate Control in Ischemic vs. Non-ischemic Patients
To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
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.
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)
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)
Changes in Functional Capacity
To observe changes in functional capacity as measured by average daily step count over the course of WCD use.

Full Information

First Posted
July 31, 2020
Last Updated
July 12, 2022
Sponsor
Zoll Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04504188
Brief Title
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Acronym
OPT-BB WOMEN
Official Title
Optimizing Beta Blocker Dosage in Women While Using the Wearable Cardioverter Defibrillator
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zoll Medical Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Rate Monitor Enhanced Treatment Optimization
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Heart Rate Monitor Enhanced Treatment Optimization
Other Intervention Name(s)
LifeVest Wearable Cardioverter Defibrillator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Control
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Heart Rate Control in Ischemic vs. Non-ischemic Patients
Description
To document the percentage achievement in effective HR control in ischemic vs. non-ischemic patients
Time Frame
90 days
Title
Change in Average Nighttime Resting Heart Rate
Description
Change in Average Nighttime Resting Heart Rate Monitored vs. Historic Heart Rate Control over the course of WCD use.
Time Frame
90 days
Title
Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Description
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)
Time Frame
90 days
Title
Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)
Description
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)
Time Frame
90 days
Title
Changes in Functional Capacity
Description
To observe changes in functional capacity as measured by average daily step count over the course of WCD use.
Time Frame
90 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Osz
Phone
412-968-3333
Email
mosz@zoll.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tara Roberts
Phone
412-968-3333
Email
tara.roberts@zoll.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Kutyifa, MD PHD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Cardiology Associates of Houston
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salazar, MD
Facility Name
CardioVoyage
City
McKinney
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abo-Auda, MD
Facility Name
CAMC
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Individual Site Status
Terminated

12. IPD Sharing Statement

Plan to Share IPD
No

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

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