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
University of Illinois at Chicago
162 participants
Dec 31, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- ≥ 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 Criteria15
- 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
Interventions
flecainide up to 150mg twice daily for the control of atrial fibrillation
sotalol up to 120mg twice daily for the control of atrial fibrillation
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT02347111