CompletedPhase 2/3

A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.

United States68 participantsStarted 2020-08-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \< 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

What they're measuring

Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol.

Timeframe: 10 minutes post drug infusion

Trial details

NCT IDNCT04134845

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-29

Results submitted2025-06-06