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Ivabradine for Rate Control in Permanent Atrial Fibrillation

Primary Purpose

Atrial Fibrillation, Atrial Fibrillation, Persistent

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ivabradine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale New Haven Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ivabradine

Arm Description

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

Outcomes

Primary Outcome Measures

Heart Rate in Daily Life
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Percent Pacing in Daily Life
Average percent pacing derived using pacemaker interrogation over 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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 31, 2019
Last Updated
June 30, 2021
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03987204
Brief Title
Ivabradine for Rate Control in Permanent Atrial Fibrillation
Official Title
Ivabradine for Rate Control in Permanent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
September 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Fibrillation, Persistent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Experimental
Arm Description
Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
Primary Outcome Measure Information:
Title
Heart Rate in Daily Life
Description
Average ventricular heart rate derived using pacemaker interrogation over 2 weeks
Time Frame
2 weeks
Title
Percent Pacing in Daily Life
Description
Average percent pacing derived using pacemaker interrogation over 2 weeks
Time Frame
2 weeks
Title
Heart Rate on Treadmill
Description
Average ventricular heart rate will be recorded after the patient exercises on a treadmill using a heart rate monitor
Time Frame
2 weeks
Title
Symptoms and Exercise Tolerance
Description
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
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Lampert, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyon Jae Lee, MD
Organizational Affiliation
Yale New Haven Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ivabradine for Rate Control in Permanent Atrial Fibrillation

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