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RiLuzole to Reduce Atrial FIb A Prospective, Double-Blind, Randomized, Placebo-Controlled Study Using Holter Monitoring (SOLUTION)

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ClinicalTrials.gov Identifier: NCT05292209
Recruitment Status : Recruiting
First Posted : March 23, 2022
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
mark munger, University of Utah

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 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Paroxysmal Drug: Riluzole 50 MG Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, double-blind, randomized, placebo-controlled, two-arm study design in patients with PAF
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blind Double Dummy
Primary Purpose: Prevention
Official Title: ASsessment Of RiLuzole To Reduce Paroxysmal Episodes of Atrial FIbrillatiON (The SOLUTION Study) A Prospective, Double-Blind, Randomized, Placebo-Controlled Study Using Holter Monitoring
Estimated Study Start Date : June 15, 2022
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole

Arm Intervention/treatment
Experimental: Active
Riluzole 50mg BID
Drug: Riluzole 50 MG
Riluzole 50mg tablets

Placebo Comparator: Control
Placebo Matching Double-Dummy Pills
Drug: Riluzole 50 MG
Riluzole 50mg tablets




Primary Outcome Measures :
  1. Episodes of Tachycardia [ Time Frame: 30 Days ]
    Number of episodes tachycardia in 1 month between riluzole 50mg BID versus matching placebo;

  2. Time to First Tachycardia Episode [ Time Frame: 30 Days ]
    Time to first episode of tachycardia between riluzole 50mg BID and placebo


Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 Days ]
    3. Safety (pro-arrhythmia, neutropenia by CBC [baseline and 1-month end] and patient signs and symptoms [weekly phone call F/U]).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05292209


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

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112-5820
Contact: Mark A Munger, Pharm.D.    801-581-6165    mmunger@hsc.utah.edu   
Contact: Ravi Ranjan, M.D.    801-587-5888    ravi.ranjan@hsc.utah.edu   
Principal Investigator: Mark A Munger, Pharm.D.         
Principal Investigator: Ravi Ranjan, M.D.         
Sub-Investigator: Przemyslaw Radwanski, Pharm.D.         
Sponsors and Collaborators
University of Utah
Ohio State University
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Responsible Party: mark munger, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT05292209    
Other Study ID Numbers: IRB_00144866
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD Sharing Plan: with Dr. Radwanski at the Ohio State University. The study protocol, statistical analysis plan, and clinical study report (only deidentified data) will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Within 30 days after completion of last patient
Access Criteria: De-identified data only

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by mark munger, University of Utah:
Atrial Fibrillation Paroxysmal, Riluzole, Holter Monitoring
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents