RecruitingPhase 2NCT05292209

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study)


Sponsor

University of Utah

Enrollment

78 participants

Start Date

Jun 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called riluzole (currently used for ALS) can reduce the recurrence of atrial fibrillation (an irregular heartbeat) in patients who are scheduled for a cardioversion procedure (an electrical shock to restore normal heart rhythm). **You may be eligible if...** - You are over 18 years old - You have had symptomatic atrial fibrillation (irregular heartbeat with symptoms) confirmed on an ECG within the past 12 months - You are scheduled for cardioversion (a procedure to restore normal heart rhythm) - You are already on blood thinners or will be started on them - You are not currently taking anti-arrhythmia medication **You may NOT be eligible if...** - Your blood pressure is very high (systolic > 180 or diastolic > 100 mmHg) - You have permanent atrial fibrillation - You have significant liver disease - You are pregnant or breastfeeding - You are already taking anti-arrhythmia medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRiluzole 50 MG

Riluzole 50mg tablets


Locations(1)

University of Utah

Salt Lake City, Utah, United States

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NCT05292209


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