What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation, such as flecainide, propafenone, amiodarone, and dronedarone, have significant side effects. Flecainide and propafenone can cause proarrhythmia, particularly in patients with structural heart disease. Amiodarone has a broad range of side effects including thyroid and liver toxicity, pulmonary issues, and skin changes. Dronedarone has been linked to an increased risk of cardiovascular events in patients with permanent AF and requires regular monitoring. These side effects highlight the need for safer alternatives, such as the neuronal-type Na+ channel blocker riluzole, which is currently under study.

What prior FDA approvals exist?

The FDA has approved several antiarrhythmic drugs for the treatment of Atrial Fibrillation (AF). These include amiodarone, dofetilide, sotalol, and dronedarone. Amiodarone and dofetilide are often used in patients with heart failure or significant left ventricular dysfunction. Sotalol is preferred in patients with coronary heart disease due to its better extracardiac side effect profile. Dronedarone, however, is not recommended for patients with permanent AF due to an increased risk of cardiovascular events. While riluzole, a neuronal-type Na+ channel blocker, is being studied for its potential in reducing AF episodes, it is not yet approved for this indication.

What other types of research exist?

Promising novel alternatives to Riluzole for Atrial Fibrillation treatment in 2024 include NIP-151, a potent IKACh blocker, GS-458967, a late sodium current inhibitor, and NIP-141, a multiple ion channel blocker. These agents have shown efficacy in preclinical models and represent potential new options for AF management.

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Neuronal-type Na+ channel blocker

Riluzole for Atrial Fibrillation (SOLUTION Trial)

Phase 2

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Will be anti-coagulated or is already anti-coagulated for planned cardioversion

Patients who are not being treated with an anti-arrhythmic agent per their physician's treatment plan

Must not have

Severe valvular heart disease

CYP 1A2 Potent Inhibitors including cimetidine, ciprofloxacin, enoxacin, rifampin, barbiturates, and fluvoxamine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

This trial tests whether riluzole, a drug used for ALS, can reduce episodes of irregular heartbeats in adults with atrial fibrillation. Riluzole has been shown to prolong survival and slow functional deterioration in patients with ALS and was approved by the FDA in 1995. The study involves monitoring heart rhythms before and after taking riluzole for a period of time. Riluzole is believed to help by blocking specific sodium channels in heart cells, potentially preventing abnormal heartbeats.

Who is the study for?

Adults over 18 with documented symptomatic Atrial Fibrillation (AF) not currently on anti-arrhythmic drugs, able to consent and follow study procedures. Excludes those with severe heart issues, certain arrhythmias, high liver enzymes, or using specific contraceptives or medications that interact with the trial drug.

What is being tested?

The trial is testing Riluzole's ability to control AF by blocking certain sodium channels in nerves. It's a randomized study comparing Riluzole against a placebo using continuous heart monitoring before and during treatment for one month each.

What are the potential side effects?

Riluzole is generally well-tolerated but can cause side effects like dizziness, gastrointestinal disturbances, elevated liver enzymes, weakness or fatigue. It does not typically cause pro-arrhythmia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking or will take blood thinners for a heart rhythm correction procedure.

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I am not on any medication for irregular heartbeats as per my doctor's advice.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious heart valve condition.

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I am not taking medications like cimetidine or ciprofloxacin.

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I had Wolff-Parkinson-White syndrome but it was successfully treated.

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I have a heart condition where the tissue becomes thick or stiff.

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I have had fainting spells or chest pain caused by an irregular heartbeat.

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I have had a type of fast heart rate or a cardiac arrest.

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I have a type of irregular heartbeat called polymorphic ventricular tachycardia.

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I have a history of torsade de pointes.

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I am not taking Class I or III antiarrhythmic drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Episodes of Tachycardia

Time to First Tachycardia Episode

Secondary study objectives

Safety of Riluzole Neutropenia

Safety of Riluzole Pro-Arrhythmia

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Riluzole 50mg BID

Group II: ControlPlacebo Group1 Intervention

Placebo Matching Double-Dummy Pills

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Riluzole 50 MG

2011

Completed Phase 2

~30

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Atrial Fibrillation (AF) include rate control, rhythm control, and emerging therapies like neuronal-type Na+ channel blockade. Rate control drugs, such as beta blockers and calcium channel blockers, slow the heart rate by affecting the AV node. Rhythm control drugs, like amiodarone and flecainide, aim to restore and maintain normal sinus rhythm by altering the heart's electrical activity. Emerging treatments, such as riluzole, target specific sodium channels to suppress atrial arrhythmias without the pro-arrhythmic risks of traditional drugs. These mechanisms are vital for AF patients to minimize symptoms, reduce stroke risk, and improve quality of life.