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Beta-Blockers for Atrial Fibrillation and Heart Failure

Q: Are there any unoccupied roles for participants in this study?

Affirmative. According to clinicaltrials.gov, the study is actively recruiting patients since it was first uploaded on February 6th 2023 and its most recent edit took place on February 28th 2023. It aims to enrol a total of 20 participants at 1 site.

Q: Can As needed rate control be administered without risk to patients?

The safety of As Needed Rate Control is estimated to be a 1 since it is still in its initial phase, with limited evidence for efficacy and safety.

Q: Could you provide the aggregate number of participants in this experiment?

Affirmative. As per the clinicaltrial.gov records, this trial is actively searching for 20 patients at a single site which was first listed on February 6th and last updated on February 28th of this year.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Exercise capacity

Secondary outcome measures

Number of participants with a composite of treatment related adverse events

Other outcome measures

Change in 6 minute walk distance

Change in Cystatin C

Change in Fructosamine

+9 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor

266 Previous Clinical Trials

3,743,671 Total Patients Enrolled

5 Trials studying Heart Failure

4,397 Patients Enrolled for Heart Failure

Nicole Habel, MDPrincipal InvestigatorUniversity of Vermont

1 Previous Clinical Trials

34 Total Patients Enrolled

1 Trials studying Heart Failure

34 Patients Enrolled for Heart Failure

Media Library

As needed rate control Clinical Trial Eligibility Overview. Trial Name: NCT05745337 — Phase 1

Heart Failure Research Study Groups: As needed rate control, Control

Heart Failure Clinical Trial 2023: As needed rate control Highlights & Side Effects. Trial Name: NCT05745337 — Phase 1

As needed rate control 2023 Treatment Timeline for Medical Study. Trial Name: NCT05745337 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unoccupied roles for participants in this study?

"Affirmative. According to clinicaltrials.gov, the study is actively recruiting patients since it was first uploaded on February 6th 2023 and its most recent edit took place on February 28th 2023. It aims to enrol a total of 20 participants at 1 site."

Answered by AI

Can As needed rate control be administered without risk to patients?

"The safety of As Needed Rate Control is estimated to be a 1 since it is still in its initial phase, with limited evidence for efficacy and safety."

Answered by AI

Could you provide the aggregate number of participants in this experiment?

"Affirmative. As per the clinicaltrial.gov records, this trial is actively searching for 20 patients at a single site which was first listed on February 6th and last updated on February 28th of this year."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Atrial Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation

Reddy, Yogesh N.V., Masaru Obokata, Frederik H. Verbrugge, Grace Lin, and Barry A. Borlaug. 2020. “Atrial Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2020.07.009.

Journal of the American College of CardiologyJournal

Determinants of Exercise Intolerance in Elderly Heart Failure Patients with Preserved Ejection Fraction

Haykowsky, Mark J., Peter H. Brubaker, Jerry M. John, Kathryn P. Stewart, Timothy M. Morgan, and Dalane W. Kitzman. 2011. “Determinants of Exercise Intolerance in Elderly Heart Failure Patients with Preserved Ejection Fraction”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2011.02.055.

clinicaltrials.govStudy

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

Nicole Habel, MD 2023. "Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05745337.

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