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Recruiting Phase 4 NCT02347111

NCT02347111 Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

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Clinical Trial Summary
NCT ID NCT02347111
Status Recruiting
Phase Phase 4
Sponsor University of Illinois at Chicago
Condition Atrial Fibrillation
Study Type INTERVENTIONAL
Enrollment 162 participants
Start Date 2020-12-31
Primary Completion 2026-06-30

Trial Parameters

Condition Atrial Fibrillation
Sponsor University of Illinois at Chicago
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 162
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2020-12-31
Completion 2026-06-30
Interventions
FlecainideSotalol

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Brief 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 Criteria

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

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