← Back to Search

Beta-Blockers for Atrial Fibrillation and Heart Failure

Phase 1

Recruiting

Led By Nicole Habel, MD

Research Sponsored by University of Vermont

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Be older than 18 years old

Must not have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months, at 12 months, at 18 months, at 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare continuous beta-blocker use and as-needed rate control of AF in patients with stage II or III heart failure.

Who is the study for?

This trial is for adults with recent atrial fibrillation, a type of irregular heartbeat. They must have an implantable cardiac monitor and be on certain heart rate control medications. Their heart's pumping function should be normal or only slightly reduced, and they may have signs of a condition where the heart is stiff but not enlarged.

What is being tested?

The study compares continuous use of beta-blockers or calcium channel blockers to using these medications only when needed for controlling heart rate in atrial fibrillation. It uses an implanted monitor to guide treatment and looks at exercise ability, AF episodes, symptoms of heart failure, health markers, and life quality.

What are the potential side effects?

Potential side effects include lower blood pressure, slower heartbeat, dizziness or lightheadedness from beta-blockers; swelling in the feet or legs from calcium channel blockers; fatigue; trouble breathing; and other individual reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on a high dose of beta-blockers or my heart rate is below 75 bpm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had atrial fibrillation for more than a year or it's permanent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months, at 12 months, at 18 months, at 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months, at 12 months, at 18 months, at 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months, at 12 months, at 18 months, at 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exercise capacity

Secondary study objectives

Number of participants with a composite of treatment related adverse events

Other study objectives

Change in quality of life by Atrial fibrillation Effect on Quality of life questionnaire score

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

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: As needed rate controlExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

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

0 / 2Eligibility criteria met