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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
Yale New Haven Hospital
New Haven, Connecticut, United States
Heart Rate in Daily Life
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Time frame: 2 weeks
Percent Pacing in Daily Life
Average percent pacing derived using pacemaker interrogation over 2 weeks
Time frame: 2 weeks
Heart Rate on Treadmill
Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor
Time frame: 2 weeks
Symptoms and Exercise Tolerance
Patients will undergo a 6 minute walk test, and symptoms and distance walked as measured by standard 6 minute walk protocol
Time frame: 2 weeks
Blood Pressure
Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes
Time frame: 2 weeks
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