NCT05292209 · University of Utah
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
(SOLUTION)
What this study is about
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).
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2023 · Source of record for eligibility and locations