Phase 3 N=68 Randomized Double-blind Treatment

A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.

Ventricular Tachycardia

Bottom Line

View on ClinicalTrials.gov: NCT04134845 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. — 4; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dantrolene/Ryanodex (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol.	4; 9	—
SECONDARY Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo.	0; 1; 0; 1; 2; 4	—

Summary

This is a randomized, placebo-controlled trial of Dantrolene (N= 84 participants) to demonstrate the feasibility of using intravenous (IV) dantrolene to study the effect of RyR2 inhibition on cardiac electrophysiology, hemodynamics, and ventricular arrhythmia inducibility in patients with structural heart disease referred for Ventricular Tachycardia (VT) ablation. The investigators will also explore the pharmacokinetic/pharmacodynamic relationship of IV dantrolene and its short-term effect on specific cardiac electrophysiologic and hemodynamic parameters.

Eligibility Criteria

Inclusion Criteria

Greater than or equal to 18 years of age
Able to give written informed consent
Referred for catheter-based VT ablation
Structural heart disease (cardiomyopathy or RV/LV scar)
Permanent pacemaker or implantable cardioverter defibrillator

Exclusion Criteria

Mechanical ventricular support (e.g. LVAD, ECMO)
NYHA class IV heart failure
LVEF 40 kg/m2)
Severe renal insufficiency (GFR<30 mL/min)
Chronic liver disease (Child Pugh class A-C)
Current use of calcium channel blockers
Neuromuscular disorder (e.g. muscular dystrophy)
Chronic obstructive pulmonary disease or restrictive lung disease requiring oxygen
Therapy or history of intubation
Pregnant or nursing
History of dysphagia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04134845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.