Comparing daily beta-blocker use to as-needed rate control for atrial fibrillation management
Improving Outcomes in Atrial Fibrillation Patients Aided by Implantable Cardiac Monitor: Evaluation of Chronic Beta-blocker Use Versus As-needed Pharmacological Rate Control
This study is testing whether taking beta-blockers every day or only when needed can help people with atrial fibrillation and heart failure feel better and improve their quality of life.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Academic / other |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT05745337 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using implantable cardiac monitors to guide as-needed pharmacological rate control in patients with atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF). Participants will be randomized to receive either continuous beta-blocker therapy or as-needed rate control, with assessments of exercise capacity, AF burden, heart failure symptoms, and quality of life conducted at baseline and six months. The study will also include long-term follow-up to monitor clinical endpoints related to heart failure and AF events over a period of up to four years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with paroxysmal or persistent atrial fibrillation and an implantable cardiac monitor.
Not a fit: Patients with long-standing persistent or permanent atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more tailored approach to managing atrial fibrillation, potentially improving patient outcomes and quality of life.
How similar studies have performed: While there have been studies on beta-blocker use in AF, this approach of using implantable monitors for guided rate control is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Burlington, Vermont
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Habel, MD — University of Vermont
- Study coordinator: Nicole Habel, MD
- Email: nicole.habel@uvmhealth.org
- Phone: 8028470000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.