CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
Dantrolene/Ryanodex +1 moredrug
Likely dose
Placebo 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04134845
NCT04134845Phase 3Completed
CompareCT.gov

A Randomized Controlled Trial of RyR2 Inhibition With Dantrolene and Susceptibility to Ventricular Arrhythmias in Patients With Structural Heart Disease.

Vanderbilt University Medical Center·interventional·Posted Oct 22, 2019·Updated Mar 10, 2026

In Brief

A Phase 3 clinical trial evaluating Dantrolene/Ryanodex and Placebo for Ventricular Tachycardia. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Tachycardia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 22, 2019
Enrollment StartAug 21, 2020
Primary CompletionMay 29, 2025
Study CompletionAug 29, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 6.7 years ago

Interventions

Dantrolene/Ryanodexdrug

muscle relaxant

Placebodrug

Controlled placebo of saline administered Intravenous; 1 mg/kg IV over 3 minutes, one time dose