Status:
COMPLETED
A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The hypothesis to be tested is that RyR2 hyperactivity in patients with structural heart disease drives proarrhythmic changes in refractoriness and conduction, and decreases cardiac contractility, whi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04134845
Start Date
August 21 2020
End Date
August 29 2025
Last Update
October 28 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232