Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
Recruiting · NCT02347111 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
FlecainideSotalol
What this trial 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). 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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed across 1 US state.
- Jesse Brown VA Medical Center - Chicago, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Illinois at Chicago - Chicago, Illinois, United States
- Advocate Christ Medical Center - Oak Lawn, Illinois, United States