Actively Recruiting
Assessment Of Riluzole To Reduce Paroxysmal Episodes of Atrial Fibrillation (The SOLUTION Study)
Led by University of Utah · Updated on 2023-11-24
78
Participants Needed
1
Research Sites
N/A
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 common heart rhythm disorder that causes episodes of irregular heartbeat and can lead to serious health problems. Researchers are evaluating riluzole, a drug currently used for amyotrophic lateral sclerosis (ALS), to see if it can reduce episodes of AF safely and effectively. The study is a phase 2, prospective, randomized, placebo-controlled trial comparing riluzole to placebo in patients with paroxysmal AF. Participants will be randomly assigned to receive either riluzole 50mg twice daily or a matching placebo for one month. Before starting the medication, patients will undergo cardioversion to restore normal heart rhythm. Heart rhythm will be continuously monitored using a chest-worn, nonadhesive Holter monitor throughout the 30-day treatment period to track AF episodes. After the initial month, patients without AF recurrence and tolerating the drug may continue riluzole in an open-label extension for an additional 90 days with follow-up phone calls. Patients will have blood tests before and after the treatment period to monitor safety, including checks for heart rhythm disturbances and blood cell counts. Weekly phone calls will assess symptoms and side effects. The main outcomes measured are the number of AF episodes and the time to the first AF episode during the 30-day treatment. Safety and tolerability of riluzole compared to placebo will also be evaluated. After the study, patients will continue care with their own doctors.
CONDITIONS
Brief Title
RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults over 18 years old with symptomatic atrial fibrillation documented by ECG within 48 hours to 12 months before enrollment
- Able to provide written informed consent and understand study procedures
- On or planned for anticoagulation 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 other reversible illness
- New York Heart Association Class IV heart failure without acute decompensation in past month
- Unstable angina, recent heart attack, coronary surgery within 3 months, or angioplasty within 1 month
- Wolff-Parkinson-White syndrome unless successfully ablated
- Infiltrative or severe valvular heart disease
- History of syncope or angina caused by ventricular arrhythmia
- History of torsade de pointes, polymorphic ventricular tachycardia, sustained monomorphic ventricular tachycardia, or cardiac arrest
- Use of Class I or III antiarrhythmic agents
- Females of childbearing potential not using approved birth control methods or not surgically sterile
- Elevated liver enzymes over 5 times normal in past 3 months
- Use of potent CYP1A2 inhibitors such as cimetidine, ciprofloxacin, rifampin, and others
- Active tobacco smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants take riluzole or placebo twice daily and undergo scheduled cardioversion after 3 days on medication. Heart rhythm is continuously monitored to assess atrial fibrillation burden.
Continuous heart rhythm monitoring for 30 days and weekly phone calls for safety follow-up
Duration - 1 day
Participants return to the clinic for blood tests to assess safety and medication effects after the 30-day treatment period.
1 visit (in-person) for blood draw
Duration - 90 days
Participants who tolerate riluzole and have no return of atrial fibrillation may continue riluzole treatment for an additional 90 days with phone call follow-up to monitor symptoms and medication tolerance.
Phone call follow-up every 14 days
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.
J
John Kirk
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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