RECRUITING

RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study)

Quick Facts

Study Start:2022-06-15
Study Completion:2024-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05292209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or Female adult patients (\> 18 years old) with a history of symptomatic AF documented electrocardiographically within \> 48 hours to 12 months before enrollment.
  2. * Is able to provide written informed consent to participate in the study and is able to understand the procedures and study requirements.
  3. * 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.
  4. * Will be anti-coagulated or is already anti-coagulated for planned cardioversion.
  5. * Is planned to undergo a cardioversion.
  6. * Patients who are not being treated with an anti-arrhythmic agent per their physician's treatment plan
  1. * Systolic BP \> 180 mmHg or Diastolic BP \> 100 mmHg;
  2. * Atrial Fibrillation due to electrolyte imbalance, hyperthyroidism, pericarditis, or other reversible illness;
  3. * NYHA FC IV Heart Failure (No ADHF Decompensation with 1 month);
  4. * Unstable Angina, AMI, coronary surgery within 3 or coronary angioplasty within 1 month of screening;
  5. * Wolff-Parkinson-White syndrome unless treated with successful ablation;
  6. * Infiltrative heart disease;
  7. * Severe valvular heart disease;
  8. * History of syncope or angina precipitated by an ventricular arrhythmia;
  9. * History of torsade de pointes;
  10. * Any polymorphic ventricular tachycardia;
  11. * Sustained monomorphic ventricular tachycardia, or cardia arrest;
  12. * Class I or III antiarrhythmic agents;
  13. * 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;
  14. * 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
  15. * Total abstinence from sexual intercourse since the last menses before study medication administration
  16. * Intrauterine device
  17. * Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream);
  18. * Aminotransferases \> 5 x ULN (Test in the last 3 months);
  19. * CYP 1A2 Potent Inhibitors including cimetidine, ciprofloxacin, enoxacin, rifampin, barbiturates, and fluvoxamine; and
  20. * Active tobacco use. (i.e., smoking)

Contacts and Locations

Study Contact

Mark A Munger, Pharm.D.
CONTACT
801-581-6165
mmunger@hsc.utah.edu
John Kirk
CONTACT
801-585-2944
john.kirk@hsc.utah.edu

Study Locations (Sites)

University of Utah
Salt Lake City, Utah, 84112-5820
United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-15
Study Completion Date2024-10-30

Study Record Updates

Study Start Date2022-06-15
Study Completion Date2024-10-30

Terms related to this study

Keywords Provided by Researchers

  • Atrial Fibrillation Paroxysmal, Riluzole, Holter Monitoring

Additional Relevant MeSH Terms

  • Atrial Fibrillation Paroxysmal