Actively Recruiting
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
Led by University of Utah · Updated on 2023-11-24
78
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
O
Ohio State University
Collaborating Sponsor
AI-Summary
What this Trial 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). 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.
CONDITIONS
Official Title
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women over 18 years old with symptomatic atrial fibrillation documented within 48 hours to 12 months before joining
- Ability to provide written informed consent and understand the study procedures
- Voluntary signing of an approved informed consent form before any study-specific procedures
- Either currently on anticoagulation or planned to be anticoagulated for cardioversion
- Planned to undergo cardioversion
- Not currently treated with anti-arrhythmic agents as per physician's plan
You will not qualify if you...
- Systolic blood pressure over 180 mmHg or diastolic blood pressure over 100 mmHg
- Atrial fibrillation caused by electrolyte imbalance, hyperthyroidism, pericarditis, or reversible illness
- New York Heart Association Class IV heart failure or acute decompensation within 1 month
- Unstable angina, recent heart attack, coronary surgery within 3 months or angioplasty within 1 month
- Wolff-Parkinson-White syndrome unless successfully treated by ablation
- Infiltrative heart disease
- Severe valvular heart disease
- History of fainting or chest pain due to ventricular arrhythmia
- History of torsade de pointes or any polymorphic ventricular tachycardia
- Sustained monomorphic ventricular tachycardia or cardiac arrest
- Use of Class I or III antiarrhythmic drugs
- Females of childbearing potential not using specified birth control methods or surgically sterile
- Elevated liver enzymes (aminotransferases over 5 times normal in last 3 months)
- Use of certain potent CYP1A2 inhibitors like cimetidine or ciprofloxacin
- Active tobacco smoking
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84112-5820
Actively Recruiting
Research Team
M
Mark A Munger, Pharm.D.
CONTACT
J
John Kirk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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