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

Last updated: February 28, 2023
Sponsor: University of Vermont
Overall Status: Active - Recruiting

Phase

1

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT05745337
00002271
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-blockerwith resting sinus rhythm heart rate < 75 bpm (documented on EKG in the last 6 monthsOR 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) leftatrial enlargement OR (3) diastolic dysfunction.

Exclusion

Exclusion Criteria:

  • Long-standing persistent or permanent atrial fibrillation (Long-standing persistent AFis defined as continuous AF of > 12 months duration. Permanent AF is defined as AFaccepted by the patient and physician and no further attempts to restore/maintainsinus rhythm will be undertaken).
  • Echocardiographic evidence of left ventricular dilation (defined as left ventricularend diastolic volume (LVEDV) index ≥ 80ml/m2 as determined by echocardiogram withinthe 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 12.5mgdaily, Bisoprolol 5mg twice daily, Nebivolol 5mg daily, Atenolol 50mg daily, Labetalol 100mg twice daily, Propranolol 40mg twice daily

Study Design

Total Participants: 20
Study Start date:
February 06, 2023
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • University of Vermont Medical Center

    Burlington, Vermont 05405
    United States

    Active - Recruiting

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