What side effects are associated with this type of intervention?

Common treatments for Ventricular Tachycardia include antiarrhythmic drugs such as amiodarone, sotalol, and procainamide. Amiodarone can cause side effects like thyroid dysfunction, pulmonary toxicity, and liver enzyme abnormalities. Sotalol may lead to bradycardia, fatigue, and risk of torsades de pointes. Procainamide can cause hypotension, lupus-like syndrome, and blood dyscrasias. For treatments similar to Dantrolene, which involves RyR2 inhibition, specific side effects are less well-documented, but potential concerns could include muscle weakness and hepatotoxicity, given Dantrolene's known profile in other contexts.

What prior FDA approvals exist?

FDA-approved treatments for Ventricular Tachycardia (VT) primarily include antiarrhythmic drugs such as amiodarone, sotalol, and procainamide. These medications work through various mechanisms, including potassium channel blockade and beta-adrenergic blockade, to stabilize cardiac electrical activity. While Dantrolene, which is being studied for its RyR2 inhibition properties, represents a novel approach, there are no specific FDA-approved drugs for VT that target RyR2 inhibition directly. Current treatments focus on managing the arrhythmia through broader electrophysiological effects rather than targeting specific molecular pathways like RyR2.

What other types of research exist?

Promising novel alternatives to Dantrolene for treating Ventricular Tachycardia in 2024 include: 1) Dronedarone, which has shown efficacy in maintaining sinus rhythm in atrial fibrillation and may be considered for VT; 2) Vernakalant, effective in rapid conversion of atrial fibrillation and potentially useful for VT; 3) Newer selective RET inhibitors like Selpercatinib and Pralsetinib, which are being explored for their antiarrhythmic properties; 4) Advanced pacing strategies and devices that minimize right ventricular pacing, such as those studied in the DAVID II and INTRINSIC RV trials. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-procedure and two hours post procedure

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

0 / 13Eligibility criteria met

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.