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

Launched by UNIVERSITY OF VERMONT · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to manage atrial fibrillation (AF), a heart condition where the heartbeat can be irregular, in patients who also have heart failure with preserved ejection fraction (HFpEF). The researchers want to find out if using an implantable cardiac monitor to guide medication on an as-needed basis is as effective as taking beta-blocker medications continuously. They will look at various outcomes, including how well patients can exercise, how much AF they experience, symptoms of heart failure, heart health markers, and overall quality of life.

To participate in this study, you need to be between 65 and 74 years old and have been diagnosed with AF within the last four weeks or longer. You should also have an implantable cardiac monitor and be on a certain dose of beta-blockers, or have a resting heart rate below 75 beats per minute. Additionally, your heart's pumping ability should be at least 50%. If you meet these criteria and decide to join, you can expect to be monitored closely and receive care that aims to improve your heart health and daily life. The trial is currently recruiting participants, and it's essential to discuss your eligibility with your healthcare provider.

Gender

ALL

Eligibility 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