Ivabradine for Rate Control in Permanent Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT03987204|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Fibrillation, Persistent||Drug: Ivabradine||Phase 1|
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.
• 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ivabradine for Rate Control in Permanent Atrial Fibrillation|
|Actual Study Start Date :||June 15, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||January 1, 2021|
Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.
Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
- Heart Rate in Daily Life [ Time Frame: 2 weeks ]Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
- Percent Pacing in Daily Life [ Time Frame: 2 weeks ]Average percent pacing derived using pacemaker interrogation over 2 weeks
- 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
- 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
- Blood Pressure [ Time Frame: 2 weeks ]Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987204
|Contact: Rachel Lampert, MD||203-785-4126||Rachel.Lampert@Yale.edu|
|United States, Connecticut|
|Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06405|
|Contact: Rachel Lampert, MD 203-785-4126 Rachel.Lampert@Yale.edu|
|Principal Investigator: Rachel Lampert, MD|
|Sub-Investigator: Hyon Jae Lee, MD|
|Principal Investigator:||Rachel Lampert, MD||Yale University|
|Study Director:||Hyon Jae Lee, MD||Yale New Haven Hospital|