NCT02347111 · University of Illinois at Chicago
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
Flecainide
flecainide up to 150mg twice daily for the control of atrial fibrillation
DRUG
Sotalol
sotalol up to 120mg twice daily for the control of atrial fibrillation
Primary outcome measures
AF burden (Percent of time subject is in atrial fibrillation)
Time frame: 12 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chicago, Illinois
- Oak Lawn, Illinois
Collaborators
Medtronic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2025 · Source of record for eligibility and locations