A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID: NCT04134845
Run by: Vanderbilt University Medical Center
People needed: 68
Starts: 2020-08-21
Expected to finish: 2025-08-29
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Mechanical ventricular support (e.g. LVAD, ECMO)
NYHA class IV heart failure
LVEF < 20%
Morbid obesity (BMI > 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

Where it is running

Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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