Using Riluzole to Reduce Atrial Fibrillation Episodes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Utah
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Mark A Munger, Pharm.D.
• Email: mmunger@hsc.utah.edu
• Phone: 801-581-6165

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• nano-second pulsed field (nsPFA) catheter ablation for paroxysmal atrial fibrillation using the CellFX system

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.