RECRUITING

Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor

Conditions

Atrial Fibrillation Diastolic Dysfunction HFpEF - Heart Failure With Preserved Ejection Fraction AF HFpEF Exercise capacity Peak oxygen consumption Beta Blocker

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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 goal of this study is to test the feasibility of guiding as-needed pharmacological rate control of atrial fibrillation (AF) by implantable cardiac monitors and to assess the impact of continuous beta-blocker therapy versus as-needed rate control on the following outcomes: (1) exercise capacity, (2) AF burden, (3) symptomatic heart failure, (4) biomarker assessment of cardiac filling pressures and cardio-metabolic health, and (5) quality of life in patients with atrial fibrillation and stage II or III heart failure with preserved ejection fraction.

Official Title

Improving Outcomes in Atrial Fibrillation Patients Aided by Implantable Cardiac Monitor: Evaluation of Chronic Beta-blocker Use Versus As-needed Pharmacological Rate Control

Quick Facts

Study Start:2023-02-06

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05745337

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:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Paroxysmal or persistent AF diagnosed in the past 4 weeks or longer * Implantable cardiac monitor (either loop recorder or pacemaker) * Current treatment with greater than minimum doses of beta-blockers OR any beta-blocker with resting sinus rhythm heart rate \< 75 bpm (documented on EKG in the last 6 months OR at enrollment visit) * Left ventricular ejection fraction ≥ 50% (reported on echocardiogram within the past 48 months) * Echocardiographic evidence of structural changes consistent with HFpEF defined by (1) left ventricular hypertrophy (septal or posterior wall thickness \> 10mm) OR (2) left atrial enlargement OR (3) diastolic dysfunction.	* Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AF is defined as continuous AF of \> 12 months duration. Permanent AF is defined as AF accepted by the patient and physician and no further attempts to restore/maintain sinus rhythm will be undertaken). * Echocardiographic evidence of left ventricular dilation (defined as left ventricular end diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram within the past 48 months. * Documentation in the electronic medical record suggesting a life expectancy less than 12 months

Inclusion Criteria

Exclusion Criteria

* Paroxysmal or persistent AF diagnosed in the past 4 weeks or longer
* Implantable cardiac monitor (either loop recorder or pacemaker)
* Current treatment with greater than minimum doses of beta-blockers OR any beta-blocker with resting sinus rhythm heart rate \< 75 bpm (documented on EKG in the last 6 months OR at enrollment visit)
* Left ventricular ejection fraction ≥ 50% (reported on echocardiogram within the past 48 months)
* Echocardiographic evidence of structural changes consistent with HFpEF defined by (1) left ventricular hypertrophy (septal or posterior wall thickness \> 10mm) OR (2) left atrial enlargement OR (3) diastolic dysfunction.

* Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AF is defined as continuous AF of \> 12 months duration. Permanent AF is defined as AF accepted by the patient and physician and no further attempts to restore/maintain sinus rhythm will be undertaken).
* Echocardiographic evidence of left ventricular dilation (defined as left ventricular end diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram within the past 48 months.
* Documentation in the electronic medical record suggesting a life expectancy less than 12 months

Contacts and Locations

Study Contact

Nicole Habel, MD

CONTACT

8028470000

nicole.habel@uvmhealth.org

Amy Henderson

CONTACT

amy.henderson@uvmhealth.org

Principal Investigator

Nicole Habel, MD

PRINCIPAL_INVESTIGATOR

University of Vermont

Study Locations (Sites)

University of Vermont Medical Center

Burlington, Vermont, 05405

United States

Collaborators and Investigators

Sponsor: University of Vermont

Nicole Habel, MD, PRINCIPAL_INVESTIGATOR, University of Vermont

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 Date2023-02-06

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-02-06

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

AF
HFpEF
Exercise capacity
Peak oxygen consumption
Beta Blocker

Additional Relevant MeSH Terms

Atrial Fibrillation
Diastolic Dysfunction
HFpEF - Heart Failure With Preserved Ejection Fraction