About this trial
Atrial fibrillation (AF) is a growing clinical problem.1 AF is a highly dynamic condition involving episodes of sinus rhythm interspersed with periods of arrhythmia, becoming more difficult to terminate over time. AF carries a substantial cost, morbidity and mortality burden. There are two important approaches to the management of AF: 1). Controlling ventricular response rate without attempting to terminate or prevent AF (rate control), and 2). Attempting to control and maintain sinus rhythm (rhythm control).2 Current rhythm control with antiarrhythmic agents (AAD) is only moderately beneficial in restoration and maintenance of sinus rhythm but produce serious adverse events. AAD selection is limited based on the potential for pro-arrhythmia, patient's age, presence of structural heart disease, and renal or hepatic dysfunction. All AF anti-arrhythmic agents are associated with harm (number needed to harm 17-119).3 There remains an important need for development of an efficacious safe AAD for the control of AF. Recent published translational studies suggest that that neuronal-type Na+ channel blockade (nNav) with riluzole, a nNav inhibitor used to manage amyotrophic lateral sclerosis (ALS), can effectively suppress triggered atrial arrhythmias.4 In two independent retrospective cohorts, riluzole-treated ALS patients significantly lowered the incidence of new-onset AF. Riluzole is well-tolerated without evidence of pro-arrhythmia.5 Therefore, to assess riluzole's effects on the reduction of paroxysmal episodes of AF, we will conduct a prospective, randomized, placebo-controlled human study using holter monitors that offer continuous electrocardiographic monitoring pre- (1 month) and with exposure to riluzole or placebo (1 month) to determine statistically superior reductions in episodes of AF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males or Female adult patients (> 18 years old) with a history of symptomatic AF documented electrocardiographically within > 48 hours to 12 months before enrollment.
Is able to provide written informed consent to participate in the study and is able to understand the procedures and study requirements.
Must voluntarily sign and date an informed consent form that approved by the University of Utah IRB before the conduct of any study-specific procedure.
Will be anti-coagulated or is already anti-coagulated for planned cardioversion.
Disqualifiers
Systolic BP > 180 mmHg or Diastolic BP > 100 mmHg;
Atrial Fibrillation due to electrolyte imbalance, hyperthyroidism, pericarditis, or other reversible illness;
NYHA FC IV Heart Failure (No ADHF Decompensation with 1 month);
Unstable Angina, AMI, coronary surgery within 3 or coronary angioplasty within 1 month of screening;
Trial design
Parallel
Treatments tested in this trial
Riluzole 50 MG
DrugRiluzole 50mg tablets
Treatment groups
Trial outcomes
Primary outcomes
Episodes of Tachycardia
Number of episodes of atrial fibrillation in 1 month between riluzole 50mg BID versus matching placebo;
Time to First Tachycardia Episode
Time to first episode of atrial fibrillation between riluzole 50mg BID and placebo
Secondary outcomes
Safety of Riluzole Pro-Arrhythmia
1\. Pro-arrhythmia measured as number of episodes of V tachycardia over 30 days
Safety of Riluzole Neutropenia
Neutropenia measured by change on CBC \[baseline and 1-month end\] and patient signs and symptoms \[weekly phone call F/U\]).
Sponsors and contacts
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University of Utah
Lead sponsor
Ohio State University
Collaborator