Testing antiarrhythmic drugs for atrial fibrillation based on genetics

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

This study is testing if two different heart medications can help people with frequent atrial fibrillation based on their genetic makeup.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Illinois at Chicago (Academic / other)
• Locations: 4 sites (Chicago, Illinois and 3 other locations)
• Trial ID: NCT02347111 on ClinicalTrials.gov

What this trial studies

This pilot study aims to enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) to evaluate the effectiveness of two different classes of antiarrhythmic drugs (AADs), Flecainide and Sotalol. Participants will be assessed in a cross-over design to gather preliminary data on how a common genetic risk allele may influence their response to these medications. The study seeks to address the variability in treatment response and improve the understanding of genetic factors contributing to AF. Ultimately, this research could pave the way for more personalized treatment strategies for patients with AF.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of symptomatic paroxysmal or persistent atrial fibrillation.

Not a fit: Patients with permanent atrial fibrillation or those who have previously undergone AF ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with atrial fibrillation.

How similar studies have performed: While the approach of using genetic factors to guide treatment is gaining traction, this specific study is among the first to directly test the impact of genetic risk alleles on the response to antiarrhythmic drugs in AF.

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 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 this trial is running

Chicago, Illinois and 3 other locations

• Jesse Brown VA Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
• Rush University Medical Center — Chicago, Illinois, United States (Not_yet_recruiting)
• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Dawood Darbar, M.D.

Conditions Atrial Fibrillation