A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Dantrolene

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 < 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