A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
NCT04134845 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2026-03-10
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.
Conditions
- Ventricular Tachycardia
Interventions
- DRUG
-
Dantrolene/Ryanodex
muscle relaxant
- DRUG
-
Controlled placebo of saline administered Intravenous; 1 mg/kg IV over 3 minutes, one time dose
Sponsors & Collaborators
-
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
William Stevenson, MD · Vanderbilt University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-21
- Primary Completion
- 2025-05-29
- Completion
- 2025-08-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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