NCT03987204

Ivabradine for Rate Control in Permanent Atrial Fibrillation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 1. 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. 2. 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. 3. 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.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Interventions

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

Timeline

• Start date: 2019-06-15
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2019-06-14
• Last updated: 2021-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study