NCT02347111RecruitingPhase 4
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 20 Jan 2015
- Start date
- 31 Dec 2020
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- University of Illinois Chicago
- Diseases
- Atrial fibrillation
- NCT number
- NCT02347111
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 162
- From 31 Dec 2020 to the primary completion date, 30 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- A history of prior AF ablation
Other illness
- Medical condition that is likely to be fatal in less than one year
- Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI
- History of severe AV node dysfunction unless an electronic pacemaker is present
Lab values
- Creatinine clearance \<40 ml/min
- Left ventricular ejection fraction \< 50%
- 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
Other
- Permanent AF or isolated atrial flutter
- Have already been tried on 2 or more AADs in the past for AF
- A reversible cause of AF (e.g., hyperthyroidism)
- Females who are pregnant or nursing
- First- or second-degree relative has already participated in the study
- Unable to adhere to study procedures that are strictly for research purposes
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Jesse Brown VA Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Advocate Christ Medical Center Coordinator of this site? Confirm its status | Oak Lawn | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.