Status:
RECRUITING
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Ohio State University
Conditions:
Atrial Fibrillation Paroxysmal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 termina...
Detailed Description
HYPOTHESIS: Riluzole will statistically reduce the number of AF episodes compared to placebo over a one-month follow-up period in patients with permanent AF (PAF). A prospective, double-blind, random...
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)
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05292209
Start Date
June 15 2022
End Date
October 30 2024
Last Update
November 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Utah
Salt Lake City, Utah, United States, 84112-5820