Trial · NCT04134845
A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
NCT04134845, Phase 2, Phase 3, Completed, Vanderbilt University Medical Center; results first posted 2025-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias. Trials, record NCT04134845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04134845
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.
- NCT number
- NCT04134845
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Ventricular Tachycardia
- Interventions
- Dantrolene/Ryanodex, Placebo
- First posted
- 2019-10-22
- Last updated
- 2026-10-08
- Results first posted
- 2025-08-15
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | 10 minutes post drug infusion | Post drug ventricular stimulation with Right Ventricle (RV) ventricular catheter in the Right Ventricle( RV) apex with increasing extra stimuli with planned decrement stimuli by 10 milliseconds (ms) to effective refractory period (ERP). Outcome is measured as Ventricular inducibility yes/no. |
| Secondary | Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | 10 minutes post drug infusion | A standardized induction protocol is performed using programmed ventricular stimulation from the Right Ventricular apex which was done pre-drug/placebo and post drug/placebo. The induction is single, double or triple extra beats of stimulation. |
| Other | Change in Heart Rate at 20 Minutes | 20 minutes | Heart rate measurement performed by standard heart rate monitors in the Electrophysiology lab. Difference between heart rate at 20 minutes post-drug infusion compared to pre-drug infusion. |
| Other | Change in Mean Arterial Blood Pressure | 20 minutes | Mean arterial blood pressure at 20 minutes vs pre-drug treatment |
| Other | Post-drug Arterial Oxygen Saturation | 20 minutes | Post-drug arterial oxygen saturation after 20 minutes as measured by arterial blood gas. |
| Other | Post-drug Mixed Venous O2 Sats- Measured From PA Catheter | 20 minutes | Hemodynamic monitoring for mixed venous O2 sats will be performed during ablation with a pulmonary artery (PA) catheter (aka. Swann-Ganz Catheter). Measurement obtained 20 minutes after drug administration. |
| Other | Mean PA Pressure | pre drug infusion and 20 minutes post drug infusion | Mean PA- mmHg; Hemodynamic monitoring for PA will be performed during ablation with pulmonary artery (PA) catheter (aka. Swann-Ganz Catheter). |
| Other | Serial Pulmonary Cap. Wedge Pressure Measurements | pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion | Measuring the Pulmonary Capillary Wedge pressure by the hemodynamic pulmonary catheter. |
| Other | Half-life | Up to 48 hours | The pharmacokinetic measurement of the time it takes for the concentration of the drug in the body to decrease by half. |
| Other | Maximum Observed Plasma Concentration | Up to 48 hours | A pharmacokinetic measure to determine the highest concentration of the drug. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | 10 minutes post drug infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | 10 minutes post drug infusion | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Serial Heart Rate Measurements | pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post infusion | |||
| OTHER_PRE_SPECIFIED | Number of Participants With a Change of Blood Pressure | 1 minute, 5 minute,10 minute, 15 minute and 20 minutes post infusion. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Serial Arterial O2 Sats | pre drug, post drug 1 minute, 5 minute, 10 minute and 20 minutes | |||
| OTHER_PRE_SPECIFIED | Serial Mixed Venous O2 Sats- Measured From PA Catheter | pre drug infusion, 1 minute , 5 minute, 10 minute and 20 minutes post drug infusion | |||
| OTHER_PRE_SPECIFIED | Serial PA Measurements | pre drug infusion , 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion | |||
| OTHER_PRE_SPECIFIED | Serial Pulmonary Cap. Wedge Pressure Measurements | pre drug infusion, 1 minute, 5 minute, 10 minute and 20 minutes post drug infusion | |||
| OTHER_PRE_SPECIFIED | Per the Pharmacokinetics Measurements That Will be Collected and Measured Offline-drug Half Life | post drug infusion at 5 minutes,10 minutes,15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours | |||
| OTHER_PRE_SPECIFIED | Maximum Observed Plasma Concentration | Post drug infusion at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 1-4 hours, 6-12 hours,16-24 hours and optional 28-36 hours |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | Dantrolene/Ryanodex | 4 | Participants | ||
| Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | Placebo | 9 | Participants | ||
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Dantrolene/Ryanodex | Single extra beats/ pre drug/placebo | 0 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Placebo | Single extra beats/ pre drug/placebo | 1 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Dantrolene/Ryanodex | Single extra beats/post drug/placebo | 0 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Placebo | Single extra beats/post drug/placebo | 1 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Dantrolene/Ryanodex | Double extra beats/pre drug/placebo | 2 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Placebo | Double extra beats/pre drug/placebo | 4 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Dantrolene/Ryanodex | Double extra beats/post drug/placebo | 1 | Participants | |
| Stage of Inducibility of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) by Standardized Ventricular Stimulation Protocol Pre and Post Drug/Placebo. | Placebo | Double extra beats/post drug/placebo | 3 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dantrolene/Ryanodex | 41 | |
| Overall Study | STARTED | Placebo | 27 | |
| Overall Study | COMPLETED | Dantrolene/Ryanodex | 29 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Dantrolene/Ryanodex | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Intensive Care Unit | Cardiac disorders | Dantrolene/Ryanodex | 5 | 29 | 5 |
| other | Intensive Care Unit | Cardiac disorders | Placebo | 2 | 22 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dantrolene/Ryanodex | 0 | 29 |
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, other adverse events | Dantrolene/Ryanodex | 5 | 29 |
| Total, other adverse events | Placebo | 2 | 22 |
| Total, serious adverse events | Dantrolene/Ryanodex | 0 | 29 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40894163 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dantrolene/Ryanodex vs Placebo: Number of Participants With Inducible Sustained Ventricular Tachycardia/ Ventricular Fibrillation (VT/VF) Utilizing Standardized Stimulation Protocol. | Trial comparisons |
| Dantrolene/Ryanodex vs Placebo: deaths from any cause | Trial comparisons |
| Dantrolene/Ryanodex vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04134845
GET https://conductscience.org/api/trials/v1/NCT04134845/registered?page=2