NCT02347111

Brief Summary

In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
2mo left

Started Dec 2020

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2020Jun 2026

First Submitted

Initial submission to the registry

January 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
5.9 years until next milestone

Study Start

First participant enrolled

December 31, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

5.5 years

First QC Date

January 20, 2015

Last Update Submit

August 19, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • AF burden (Percent of time subject is in atrial fibrillation)

    Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode.

    12 months

Secondary Outcomes (1)

  • AF Effect on QualiTy-of-life [AFEQT]

    12 months

Study Arms (2)

flecainide 1st

EXPERIMENTAL

flecainide x 6 months, then crossover to sotalol x 6 months

Drug: FlecainideDrug: Sotalol

sotalol 1st

EXPERIMENTAL

sotalol x 6 months, then crossover to flecainide x 6 months

Drug: FlecainideDrug: Sotalol

Interventions

FlecainideDRUG

flecainide up to 150mg twice daily for the control of atrial fibrillation

flecainide 1stsotalol 1st
SotalolDRUG

sotalol up to 120mg twice daily for the control of atrial fibrillation

flecainide 1stsotalol 1st

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF
  • ECG that was recorded within 1 month of randomization showing AF
  • Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD
  • Able to give informed consent

You may not qualify if:

  • Permanent AF or isolated atrial flutter
  • Cardiac or thoracic surgery within the previous 6 months
  • Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital)
  • Medical condition that is likely to be fatal in less than one year
  • A history of prior AF ablation
  • Have already been tried on 2 or more AADs in the past for AF
  • Creatinine clearance \<40 ml/min
  • Left ventricular ejection fraction \< 50%
  • Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI
  • Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc\>480 ms in females and \>460 ms in males at baseline
  • A reversible cause of AF (e.g., hyperthyroidism)
  • Females who are pregnant or nursing
  • History of severe AV node dysfunction unless an electronic pacemaker is present
  • First- or second-degree relative has already participated in the study
  • Unable to adhere to study procedures that are strictly for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

FlecainideSotalol

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Central Study Contacts

Dawood Darbar, M.D.

CONTACT

6158879032darbar@uic.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 27, 2015

Study Start

December 31, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations

US(4)