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

February 28, 2023 updated by: Nicole Habel, MD, University of Vermont

Improving Outcomes in Atrial Fibrillation Patients Aided by Implantable Cardiac Monitor: Evaluation of Chronic Beta-blocker Use Versus As-needed Pharmacological Rate Control

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise capacity
Time Frame: At time of randomization and 6 months afterwards.
Change in peak oxygen consumption during cardiopulmonary exercise testing
At time of randomization and 6 months afterwards.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a composite of treatment related adverse events
Time Frame: At 6 months, at 12 months, at 18 months, at 24 months
Number of heart failure hospitalization, unplanned hospitalization for atrial fibrillation, stroke or transient ischemic attack, acute coronary syndrome in both treatment arms
At 6 months, at 12 months, at 18 months, at 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a composite of treatment related heart failure events
Time Frame: At 6 months, at 12 months, at 18 months, at 24 months
Heart failure events: diuretic drug change, emergency room visit
At 6 months, at 12 months, at 18 months, at 24 months
Number of participants with a composite of treatment related atrial fibrillation events
Time Frame: At 6 months, at 12 months, at 18 months, at 24 months
Atrial fibrillation events: planned hospitalization, emergency room visit, cardioversion, antiarrhythmic medication initiation
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
Time Frame: At time of randomization and 6 months afterwards.
Score ranges from 0-105 with higher scores meaning worse quality of life
At time of randomization and 6 months afterwards.
Change in quality of life by Atrial fibrillation Effect on Quality of life questionnaire score
Time Frame: At time of randomization and 6 months afterwards.
Score ranges from 0-100 with higher scores meaning better quality of life
At time of randomization and 6 months afterwards.
Change in NTproBNP
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in hsTroponin
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in HbA1c
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in Fructosamine
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in Cystatin C
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in 6 minute walk distance
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in device detected activity level
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.
Change in atrial fibrillation burden recorded by implantable cardiac monitor
Time Frame: At time of randomization and 6 months afterwards.
At time of randomization and 6 months afterwards.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Nicole Habel, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00002271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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