Recruiting

Antiarrhythmic Drugs

Sponsor:

University of Illinois at Chicago

Code:

NCT02347111

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Flecainide

Sotalol

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT02347111

Start date

Dec 31, 2020

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: flecainide 1st

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

experimental: sotalol 1st

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

Interventions

Flecainide

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

Sotalol

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

Primary outcome measure

  • AF burden (Percent of time subject is in atrial fibrillation) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Dawood Darbar, M.D.

6158879032darbar@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Dawood J Darbar, M.D.

6158879032darbar@uic.edu

Principal Investigator:

Dawood Darbar, M.D.

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-08-24.