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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 : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ivabradine for Rate Control in Permanent Atrial Fibrillation
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivabradine

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.




Primary Outcome Measures :
  1. Heart Rate in Daily Life [ Time Frame: 2 weeks ]
    Average ventricular heart rate derived using pacemaker interrogation over 2 weeks

  2. Percent Pacing in Daily Life [ Time Frame: 2 weeks ]
    Average percent pacing derived using pacemaker interrogation over 2 weeks

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 2 weeks ]
    Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel Lampert, MD 203-785-4126 Rachel.Lampert@Yale.edu

Locations
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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         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Rachel Lampert, MD Yale University
Study Director: Hyon Jae Lee, MD Yale New Haven Hospital

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03987204     History of Changes
Other Study ID Numbers: 2000022064
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes