Clinical trial NCT03987204: Ivabradine for Rate Control in Permanent Atrial Fibrillation
Official title: Ivabradine for Rate Control in Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Atrial Fibrillation, Persistent
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Heart Rate in Daily Life
timeFrame: 2 weeks
measure: Percent Pacing in Daily Life
timeFrame: 2 weeks
measure: Heart Rate on Treadmill
timeFrame: 2 weeks
measure: Symptoms and Exercise Tolerance
timeFrame: 2 weeks
Secondary outcomes:
measure: Blood Pressure
timeFrame: 2 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Rachel Lampert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale New Haven Hospital
name: Hyon Jae Lee, MD
role: STUDY_DIRECTOR
References: