Ivabradine for Rate Control in Permanent Atrial Fibrillation

NCT03987204 | Completed Phase 1 FDA Drug

• 1 other identifier: 2000022064
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation, Persistent

Outcome Measures

Primary Outcomes (4)

• 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 (1)

• Blood Pressure

  2 weeks

Study Arms (1)

Ivabradine

EXPERIMENTAL

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

Drug: Ivabradine

Interventions

Ivabradine DRUG

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

Ivabradine

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06405, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rachel Lampert, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Hyon Jae Lee, MD

  Yale New Haven Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 14, 2019
• Study Start: June 15, 2019
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)