RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-08
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04504188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mike Osz
CONTACT
412-968-3333
mosz@zoll.com
Tara Roberts
CONTACT
412-968-3333
tara.roberts@zoll.com

Principal Investigator

Valentina Kutyifa, MD PHD
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

TriHealth Hatton Research Institute
Cincinnati, Ohio, 45242
United States
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
United States
CardioVoyage
McKinney, Texas, 75020
United States
CAMC
Charleston, West Virginia, 25304
United States

Collaborators and Investigators

Sponsor: Zoll Medical Corporation

  • Valentina Kutyifa, MD PHD, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-08
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-03-08
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiomyopathies
  • Heart Failure