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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
Must not have
Current use of calcium channel blockers
Current therapy or history of intubation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure, post drug infusion at 0, 5, 10, 15, 20 minutes

Summary

This trial tests if Dantrolene, given through an injection, can help patients with heart disease by calming overactive parts of their hearts to prevent dangerous rhythms. Dantrolene has been shown to protect the heart in various studies.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking calcium channel blockers.
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I have been intubated or am currently on a breathing machine.
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I have chronic liver disease.
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I need oxygen due to a chronic lung condition.
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My kidney function is severely reduced.
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I have a history of difficulty swallowing.
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I have severe heart failure.
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My BMI is over 40.
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I have a neuromuscular disorder like muscular dystrophy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acoustic Stimulation
Secondary study objectives
Stage of inducibility by standardized ventricular stimulation protocol of the sustained VT/VF
Other study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ventricular Tachycardia (VT) include antiarrhythmic drugs, catheter ablation, and implantable cardioverter-defibrillators (ICDs). Antiarrhythmic drugs, such as amiodarone and sotalol, work by altering the electrical signals in the heart to prevent abnormal rhythms. Catheter ablation targets and destroys small areas of heart tissue that cause abnormal electrical signals. ICDs monitor heart rhythms and deliver shocks to correct VT. Dantrolene, studied for its RyR2 inhibition, stabilizes the ryanodine receptor, reducing calcium leak from the sarcoplasmic reticulum, which is crucial in preventing arrhythmias. Understanding these mechanisms helps tailor treatments to stabilize heart rhythms and prevent life-threatening episodes in VT patients.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
894 Previous Clinical Trials
934,499 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
~0 spots leftby Nov 2024