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Riluzole for Paroxysmal Atrial Fibrillation Study

This study is testing if a medication called Riluzole (50mg tablets) can help reduce episodes of an irregular heartbeat called paroxysmal atrial fibrillation (PAF). PAF is when your heart sometimes beats irregularly, then returns to a normal rhythm. Researchers want to see if Riluzole can lower the number of these episodes and how quickly they happen. You might be able to join if you are an adult (18 years or older) with a history of symptomatic PAF that has been documented by an electrocardiogram (ECG) within the last year. The study plans to enroll 78 participants. The study's success will be measured by looking at how many episodes of a fast heartbeat (tachycardia) occur and how long it takes for the first episode to happen over 30 days.

Study design
This is a double-blind, randomized study, meaning neither you nor your doctor will know if you are receiving Riluzole or a placebo (an inactive pill). It will include 78 participants.
What's involved
You would take Riluzole 50mg twice a day (morning and early evening) or a matching placebo. You will have weekly phone calls to check on your signs and symptoms, and blood tests (CBC) at the beginning and end of the 1-month study period.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 30 days after starting the medication to measure episodes of tachycardia and time to the first episode.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05292209

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

Recruiting
PHASE2Ages 18+InterventionalPrevention
University of Utah
~78 participants
Updated 2023-11-24 on ClinicalTrials.gov
What's tested:Riluzole 50 MG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Episodes of Tachycardia
Measured over 30 Days
+1 more outcome measured

Conditions

Atrial Fibrillation Paroxysmal

Explore related trials

Atrial Fibrillation

NCT05292209

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Utah

    Salt Lake City, Utahstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Mark A Munger, Pharm.D.
[email protected]
801-581-6165
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Episodes of Tachycardia30 Days

    Number of episodes of atrial fibrillation in 1 month between riluzole 50mg BID versus matching placebo;

  • Time to First Tachycardia Episode30 Days

    Time to first episode of atrial fibrillation between riluzole 50mg BID and placebo