ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study)
University of Utah
Summary
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.
Description
HYPOTHESIS: Riluzole will statistically reduce the number of AF episodes compared to placebo over a one-month follow-up period in patients with permanent AF (PAF). A prospective, double-blind, randomized, placebo-controlled, two-arm study design in patients with PAF will be conducted to determine efficacy by: 1. Number of episodes tachycardia in 1 month between riluzole 50mg BID versus matching placebo; 2. Time to first episode of tachycardia between riluzole 50mg BID and placebo; and 3. Safety (pro-arrhythmia, neutropenia by CBC \[baseline and 1-month end\] and patient signs and symptoms \[…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Is planned to undergo a cardio…
Interventions
- DrugRiluzole 50 MG
Riluzole 50mg tablets
Location
- University of UtahSalt Lake City, Utah