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

Atrial Fibrillation Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Patients ≥ 18 years of age with paroxysmal or persistent AF who have an implantable cardiac monitor (either loop recorder or pacemaker) and who are receiving daily beta-blocker therapy will be screened for meeting the inclusion/exclusion criteria.

Trial participants will then be randomized into the daily beta-blocker or as-needed pharmacological rate control.

At baseline and six months trial participants will undergo assessment of the following measures:

• Assessment of Quality of life using the Minnesota Living with Heart Failure Questionnaire and the Atrial Fibrillation Effect on Quality of life Questionnaire.

• Blood draw

• Cardiopulmonary exercise test, 6 Minute Walk Test and average daily activity level via integrated accelerometer of the implantable cardiac monitor (if available).

• Assessment of AF burden

Study participants may opt into long-term follow up visits at 12, 18 and 24 months.

Chart review will continue for up to 4 years after enrollment for the purpose of monitoring clinical endpoints:

• Heart failure events (diuretic drug change, emergency room visit, hospitalization)

• AF events (hospitalization, emergency room visit, cardioversion, antiarrhythmic medication initiation)

• Stroke or transient ischemic attack

• Myocardial infarction ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diastolic Dysfunction

• NCT number: NCT05745337
• Study type: Interventional
• Source: University of Vermont
• Contact: Nicole Habel, MD
• Phone: 8028470000
• Email: nicole.habel@uvmhealth.org
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2023
• Completion date: December 31, 2025