Ivabradine for Rate Control in Permanent Atrial Fibrillation

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03987204
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Atrial Fibrillation, Persistent	Drug: Ivabradine	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ivabradine for Rate Control in Permanent Atrial Fibrillation
• Actual Study Start Date: Jun 15, 2019
• Actual Primary Completion Date: Sep 17, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ivabradine Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.	Drug: Ivabradine; Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.

Outcome Measures

Primary Outcome Measures

1. Heart Rate in Daily Life [2 weeks]

   Average ventricular heart rate derived using pacemaker interrogation over 2 weeks

2. Percent Pacing in Daily Life [2 weeks]

   Average percent pacing derived using pacemaker interrogation over 2 weeks

3. Heart Rate on Treadmill [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 [2 weeks]

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

Secondary Outcome Measures

1. Blood Pressure [2 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Hospital	New Haven	Connecticut	United States	06405

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Rachel Lampert, MD, Yale University
• Study Director: Hyon Jae Lee, MD, Yale New Haven Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03987204
• Other Study ID Numbers: 2000022064
• First Posted: Jun 14, 2019
• Last Update Posted: Jul 2, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jul 2, 2021