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Ryanodine Receptor Inhibitor

Dantrolene for Ventricular Arrhythmias

Phase 2 & 3
Waitlist Available
Led By William Stevenson, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of structural heart disease (cardiomyopathy or RV/LV scar)
Greater than or equal to 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure, post drug infusion at 0, 5, 10, 15, 20 minutes
Awards & highlights

Study Summary

This trial is testing whether the drug dantrolene can help treat heart conditions by studying its effects on the heart's electrophysiology, hemodynamics, and ability to induce ventricular arrhythmias.

Who is the study for?
This trial is for adults with a rapid heartbeat condition called ventricular tachycardia, who are referred for VT ablation and have structural heart disease. They must be able to consent and not have severe heart failure, morbid obesity, major kidney or liver issues, neuromuscular disorders, severe lung disease requiring oxygen, or be on certain medications like calcium channel blockers.Check my eligibility
What is being tested?
The study tests if Dantrolene can affect cardiac electrophysiology and reduce the inducibility of ventricular arrhythmias in patients with heart structure problems. It's a randomized trial where half the participants will receive Dantrolene while the other half will get a placebo.See study design
What are the potential side effects?
Dantrolene may cause side effects such as muscle weakness, drowsiness, nausea, diarrhea; it might also affect liver function. Since this is an investigational study specific to heart conditions, close monitoring for any cardiovascular-related side effects would occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a heart condition involving the heart muscle or scarring.
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I am 18 years old or older.
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I have a heart condition involving the heart muscle or scarring.
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I am referred for a special heart rhythm correction procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-procedure and two hours post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-procedure and two hours post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acoustic Stimulation
Secondary outcome measures
Stage of inducibility by standardized ventricular stimulation protocol of the sustained VT/VF
Other outcome measures
Area under the concentration-time curve from zero to infinity
Arterial Blood Gas - base excess
Arterial Blood Gas - pCO2
+22 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dantrolene/RyanodexExperimental Treatment1 Intervention
Dantrolene/Ryanodex; intravenous administration of dantrolene; 1 mg/ kg IV over 3 minute, one time dose
Group II: PlaceboPlacebo Group1 Intervention
controlled placebo of saline administered Intravenous; 1 mg/kg IV over 3 minutes, one time dose

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,108 Total Patients Enrolled
William Stevenson, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
Tulane University School Of Medicine (Medical School)
Ucla Medical Center (Residency)
1 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

Dantrolene/Ryanodex (Ryanodine Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04134845 — Phase 2 & 3
Ventricular Tachycardia Research Study Groups: Dantrolene/Ryanodex, Placebo
Ventricular Tachycardia Clinical Trial 2023: Dantrolene/Ryanodex Highlights & Side Effects. Trial Name: NCT04134845 — Phase 2 & 3
Dantrolene/Ryanodex (Ryanodine Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04134845 — Phase 2 & 3
Ventricular Tachycardia Patient Testimony for trial: Trial Name: NCT04134845 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard indication for Dantrolene/Ryanodex?

"Dantrolene/Ryanodex is most commonly used to treat cerebrovascular accidents. However, it can also be effective in treating other conditions such as spinal cord injuries, malignant hyperthermia, and spasticity."

Answered by AI

Are people still being recruited for this experiment?

"This trial, which is currently seeking participants, was originally posted on August 21st, 2020. The listing was last edited on October 1st, 2022 according to the clinicaltrials.gov website."

Answered by AI

How many individuals are participating in this experiment?

"According to the listings on clinicaltrials.gov, this trial is still recruiting patients. The study was first posted on 8/21/2020, and the 84th participant will likely be enrolled at 1 site."

Answered by AI

Are there any other examples where Dantrolene/Ryanodex has been studied?

"Currently, there are 5 clinical trials being run researching Dantrolene/Ryanodex. 1 of those live clinical trials is in Phase 3. While the many trials for Dantrolene/Ryanodex are based in Saint Louis, Missouri, there are 6 locations running trials for this treatment."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I am current on drugs to help with the arrythmia that have fair control of my arrythmia.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the screening process?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
William Stevenson 2020. "A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04134845.
~2 spots leftby Jun 2024
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