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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont

Criteria

Inclusion 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.

Exclusion Criteria:

• 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

Minimum dosage of beta-blocker therapy to meet enrollment criterion:

Metoprolol tartrate 25mg twice daily, Metoprolol succinate 50mg daily, Carvedilol 12.5mg daily, Bisoprolol 5mg twice daily, Nebivolol 5mg daily, Atenolol 50mg daily, Labetalol 100mg twice daily, Propranolol 40mg twice daily