Recruiting
Phase 1

Beta-blocker vs. Rate Control

Sponsor:

University of Vermont

Code:

NCT05745337

Conditions

Atrial Fibrillation

Diastolic Dysfunction

HFpEF - Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

As needed pharmacological rate control with beta-blocker (metoprolol tartrate, metoprolol succinate) or calcium channel blocker (diltiazem, verapamil)

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Diastolic Dysfunction

HFpEF - Heart Failure With Preserved Ejection Fraction

Study ID

NCT05745337

Start date

Feb 6, 2023

Status verified date

Feb, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Patients randomized to the control arm will continue taking their daily beta-blocker for rate control of atrial fibrillation

experimental: As needed rate control

Patients randomized to the experimental arm will stop their daily beta-blocker and take as needed rate control guided by their implantable cardiac monitor

Interventions

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

Primary outcome measure

  • Exercise capacity [ Time Frame: At time of randomization and 6 months afterwards. ]

Central Contacts and Locations

Central contacts

Nicole Habel, MD

8028470000nicole.habel@uvmhealth.org

Amy Henderson

amy.henderson@uvmhealth.org

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Nicole Habel, MD

nicole.habel@uvmhealth.org

More Information

Sponsor

University of Vermont

Last update posted

Mar 3, 2023

Last verified

Feb, 2023

Keywords

  • AF
  • HFpEF
  • Exercise capacity
  • Peak oxygen consumption
  • Beta Blocker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2023-03-03.