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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Vermont
University of Vermont Medical Center
RECRUITING
Burlington
Contact Information
Primary
Nicole Habel, MD
nicole.habel@uvmhealth.org
8028470000
Backup
Amy Henderson
amy.henderson@uvmhealth.org
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 20
Treatments
No_intervention: Control
Patients randomized to the control arm will continue taking their daily beta-blocker for rate control of atrial fibrillation
Experimental: As needed rate control
Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor
Sponsors
Leads: University of Vermont

This content was sourced from clinicaltrials.gov