A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

2018-1299

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.

2020-12-31

2025-06-30

2025-06-30

Recruiting

Early phase I

162

Inclusion Criteria: * ≥ 18 years of age * Patients of African, European, and Hispanic descent * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 162, 'type': 'ESTIMATED'}}

2023-11-29