Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago; Vanderbilt University
• Collaborator: Medtronic
• Treatments: Anti-Arrhythmia Agents; Flecainide; Sotalol

Criteria

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