Ivabradine for Rate Control in Permanent Atrial Fibrillation | NCT03987204

Studies
Ivabradine for Rate Control in Permanent Atrial Fibrillation

NCT03987204

Sponsor

Yale University

Status

Completed

Last Update Posted

Jul 2, 2021Actual

Enrollment

4Actual

Phase

Phase 1

Conditions

Atrial Fibrillation
Atrial Fibrillation, Persistent

Interventions

Ivabradine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2019Actual

Primary Completion Date

Sep 17, 2019Actual

Completion Date

Sep 17, 2019Actual

First Submitted Date

May 31, 2019

First Submission Date that Met QC Criteria

Jun 13, 2019

First Posted Date

Jun 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2021

Last Update Posted Date

Jul 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ivabradine	Experimental	Patients with permanent atrial fibrillation and previously implanted pacemakers who will be started on ivabradine.	Drug: Ivabradine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ivabradine	Drug	Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.	Ivabradine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Blood Pressure	Blood pressures will be monitored using a blood pressure cuff with the patient at rest for 10 minutes	2 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel Lampert, MD	Yale University	Principal Investigator
Hyon Jae Lee, MD	Yale New Haven Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale New Haven Hospital		New Haven	Connecticut	06405	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided