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Completed

NCT Number: NCT03987204

Ivabradine for Rate Control in Permanent Atrial Fibrillation

Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and previously-implanted pacemakers.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation, Persistent Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06405, United States

About this study

In a simple cross-over study, the investigators will evaluate the impact of oral Ivabradine on exercise treadmill test, percent pacing as stored in pacemaker diagnostics, and 6 minute walk test.

Aim/Hypotheses

  • To determine if the addition of Ivabradine to baseline cardiac medications slows mean and maximum heart rates in permanent atrial fibrillation
  • Ivabradine will lower mean and maximum heart rates on treadmill exercise test, without lowering blood pressure
  • Ivabradine will increase percent pacing, and lower rates over time as shown on pacemaker diagnostic data
  • Ivabradine will improve exertional symptoms and exercise tolerance due to atrial fibrillation as measured by the Borg's scale during a six-minute walk test.

Study Design

  • Patients with permanent atrial fibrillation will undergo baseline exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score.
  • Oral Ivabradine will be started at 5 mg twice daily, and up-titrated to a maximum dose of 7.5 mg twice daily at 7 days if percent pacing has not increased significantly or rates have not slowed more than 20bpm.
  • Exercise treadmill test, measurement of heart rates and percent pacing from pacemaker diagnostics, and a 6 minute walk test with symptomatic assessment of dyspnea using the Borg's scale score will be repeated at 2 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with stable blood pressures with permanent atrial fibrillation and implanted pacemaker pacing less than 50% of the time, with or without concomitant beta blocker or calcium channel blocker use

Exclusion criteria

  • Patients with uncontrolled hypertension will be excluded
  • To eliminate confounding effects, patients on Digoxin therapy will be excluded
  • Patients on anti-arrhythmic therapy
  • Patients with pre-excitation on EKG
  • Patients who pace > 50% of the time
  • Patients with severe Child-Pugh C hepatic impairment

Treatment and study plan

Ivabradine

Drug

Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.

Primary outcomes

  1. Heart Rate in Daily Life

    Time frame: 2 weeks

    Average ventricular heart rate derived using pacemaker interrogation over 2 weeks

  2. Percent Pacing in Daily Life

    Time frame: 2 weeks

    Average percent pacing derived using pacemaker interrogation over 2 weeks

  3. Heart Rate on Treadmill

    Time frame: 2 weeks

    Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor

  4. Symptoms and Exercise Tolerance

    Time frame: 2 weeks

    Patients will undergo a 6 minute walk test, and symptoms and distance walked as measured by standard 6 minute walk protocol

Secondary outcomes

  1. Blood Pressure

    Time frame: 2 weeks

    Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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