NCT05745337

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DRUG	As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil)	Patients will stop their daily beta-blocker and take as-needed rate control (beta-blocker or calcium channel blocker) guided by their implantable cardiac monitor

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2023-02-27
• Last updated: 2023-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study