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

NCT05745337 | Unknown Phase 1 FDA Drug

• 1 other identifier: 00002271
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Change in peak oxygen consumption during cardiopulmonary exercise testing

  At time of randomization and 6 months afterwards.

Secondary Outcomes (1)

• Number of participants with a composite of treatment related adverse events

  At 6 months, at 12 months, at 18 months, at 24 months

Other Outcomes (12)

• Number of participants with a composite of treatment related heart failure events

  At 6 months, at 12 months, at 18 months, at 24 months

• Number of participants with a composite of treatment related atrial fibrillation events

  At 6 months, at 12 months, at 18 months, at 24 months

• Change in quality of life by Minnesota Living with heart failure questionnaire score

  At time of randomization and 6 months afterwards.

Study Arms (2)

Control

NO INTERVENTION

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

As needed rate control

EXPERIMENTAL

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

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

Interventions

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

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

As needed rate control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Adrenergic beta-Antagonists; Metoprolol; Calcium Channel Blockers; Diltiazem; Verapamil

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines

Study Officials

• Nicole Habel, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Habel, MD

CONTACT

8028470000; nicole.habel@uvmhealth.org

Amy Henderson

CONTACT

amy.henderson@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 27, 2023
• Study Start: February 6, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)