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

NCT04504188 | Recruiting FDA Device

• 1 other identifier: 90D0229
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiomyopathies; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Heart Rate Control in Ischemic vs. Non-ischemic Patients

  90 days

• Change in Average Nighttime Resting Heart Rate

  90 days

• Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  90 days

• Changes in (European Quality of Life 5 Dimension Questionnaire (EQ-5D-5L)

  90 days

• Changes in Functional Capacity

  90 days

Study Arms (1)

Heart Rate Monitor Enhanced Treatment Optimization

EXPERIMENTAL

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

Interventions

Heart Rate Monitor Enhanced Treatment Optimization DEVICE

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.

Also known as: LifeVest Wearable Cardioverter Defibrillator

Heart Rate Monitor Enhanced Treatment Optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (4)

TriHealth Hatton Research Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

Texas Cardiology Associates of Houston

Kingwood, Texas, 77339, United States

TERMINATED

CardioVoyage

McKinney, Texas, 75020, United States

RECRUITING

CAMC

Charleston, West Virginia, 25304, United States

TERMINATED

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Valentina Kutyifa, MD PHD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Osz

CONTACT

412-968-3333; mosz@zoll.com

Tara Roberts

CONTACT

412-968-3333; tara.roberts@zoll.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 31, 2020
• First Posted: August 7, 2020
• Study Start: March 8, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)