Using Riluzole to Reduce Atrial Fibrillation Episodes

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

This study is testing if the medication Riluzole can help reduce episodes of irregular heartbeats in adults with paroxysmal atrial fibrillation compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Utah (other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT05292209 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of Riluzole in reducing episodes of paroxysmal atrial fibrillation (AF) compared to a placebo over a one-month period. It employs a double-blind, randomized, placebo-controlled design, enrolling adult patients with documented symptomatic AF. Participants will receive either Riluzole 50mg twice daily or a matching placebo, with outcomes measured by the number of tachycardia episodes and time to first episode, alongside safety assessments for adverse effects. The study aims to provide a safer alternative to current antiarrhythmic agents, which often have significant side effects.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a history of symptomatic paroxysmal atrial fibrillation who are not currently on anti-arrhythmic medications.

Not a fit: Patients with atrial fibrillation due to reversible causes or those with severe heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new, safer treatment option for patients suffering from paroxysmal atrial fibrillation.

How similar studies have performed: While the use of Riluzole in this context is novel, other studies have explored various agents for atrial fibrillation management with mixed results.

Eligibility criteria

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

Exclusion Criteria:

* 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;
* Wolff-Parkinson-White syndrome unless treated with successful ablation;
* Infiltrative heart disease;
* Severe valvular heart disease;
* History of syncope or angina precipitated by an ventricular arrhythmia;
* History of torsade de pointes;
* Any polymorphic ventricular tachycardia;
* Sustained monomorphic ventricular tachycardia, or cardia arrest;
* Class I or III antiarrhythmic agents;
* Females of childbearing age. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile \[bilateral tubal ligation, bilateral oophorectomy, or hysterectomy\]) or is practicing 1 of the following medically acceptable methods of birth control for at least one full menstrual cycle prior to screening (see below), and agrees to continue with the regimen from the time of screening, throughout the entire study they are excluded;
* Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 3 full cycles (based on the subject's usual menstrual cycle period) before study medication administration
* Total abstinence from sexual intercourse since the last menses before study medication administration
* Intrauterine device
* Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream);
* Aminotransferases \> 5 x ULN (Test in the last 3 months);
* CYP 1A2 Potent Inhibitors including cimetidine, ciprofloxacin, enoxacin, rifampin, barbiturates, and fluvoxamine; and
* Active tobacco use. (i.e., smoking)

Where this trial is running

Salt Lake City, Utah

• University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Mark A Munger, Pharm.D.

Conditions: Atrial Fibrillation Paroxysmal, Atrial Fibrillation Paroxysmal, Riluzole, Holter Monitoring