Ivabradine for Rate Control in Permanent Atrial Fibrillation

NCT ID: NCT03987204

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-09-17

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ivabradine

Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.

Group Type: EXPERIMENTAL

Ivabradine

Intervention Type: DRUG

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

Interventions

Ivabradine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Lampert, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Hyon Jae Lee, MD

Role: STUDY_DIRECTOR

Yale New Haven Hospital

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2000022064

Identifier Type: -

Identifier Source: org_study_id