RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

Launched by UNIVERSITY OF UTAH · Mar 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called riluzole to see if it can help reduce episodes of paroxysmal atrial fibrillation (AF), a condition where the heart beats irregularly and can lead to serious health issues. Currently, treatments for AF can have significant side effects and are not always effective. Riluzole is already used to treat another condition, amyotrophic lateral sclerosis (ALS), and early studies suggest it may help lower the chances of developing AF without causing harmful effects. In this trial, participants will be monitored continuously using a special device called a Holter monitor for one month before and one month after taking either riluzole or a placebo (a dummy pill) to see if it helps reduce their AF episodes.

To be eligible for the study, participants need to be adults over 18 years old who have had symptoms of AF documented within the last year. They should also be preparing for a procedure called cardioversion, which is a way to restore a normal heart rhythm. Participants must be able to give their consent to join the study and will not be taking any other anti-arrhythmic medications during this time. Those with certain health conditions, such as severe heart disease or recent heart surgery, will not be included. Throughout the study, participants will be closely monitored, and their experiences will help researchers understand if riluzole is a safe and effective treatment for this common heart issue.

Gender

ALL

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)