Dantrolene VT study

Phase 1

Recruiting

• Conditions: Patients with acute or chronic heart failure and sustained ventricular tachycardia and those withSVT

• Registration Number: JPRN-jRCTs061180078
• Lead Sponsor: Kobayash Shigeki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients with acute or chronic heart failure and sustained ventricular tachycardia(SVT) and those with CPVT and ARVC complicated with SVT:
1) age; from 20 to < 85 years old
2) eligible for man and female
3) Patients with heart failure (myocardial infarction, cardiac sarcoidosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, CPVT, ARVC et al.), complicated with VT
4) Patient who receive the treatment according to the guidelines of diagnosis and treatment of acute and chronic heart failure (JCS2017/JHFS2017) and the guidelines of drug treatment of arrhythmias (JCS2009)
5) eligible for patients with and without ICD (CRTd)
6) patients with sustained VT who are refractory to oral administration of amiodarone or intravenous infusion of amiodarone, and those with sustained VT who cannot undergo amiodarone medication because of its severe adverse event
7) patiens who provided written informed consent before participating in the study and for whom regal representative gave informed consent

Exclusion Criteria

1)patients with COPD and severe dysfunction of respiratory function
2)patient diagnosed with myasthenia gravis
3)patients with severe liver dysfunction
4)history of allergy and hypersensitivity for dantrolene
5)patients with severe valvular heart disease and severe HOCM
6)cancer patients
7)paients who primary investigator and investigators consider as unsuitable for the present study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Safety

Secondary Outcome Measures

Name	Time	Method
1)changes of HR and BP between pre-dantrolene and post- dantrolene administration <br>2)changes of occurrence of VPCs/h, VPC, NSVT, SVT between pre-dantrolene and post-dantrolene administration<br>3)changes of indices of cardiac function of echocardiography<br>4)effect of dantrolene on PQ, QRS, QT intervals between pre-dantrolene and post-dantrolene administration<br>5) effective concentration of dantrolene for termination of VT or prevenrtion of VT<br>6) changes of BNP between pre-dantrolene and post- dantrolene administration<br>7)effect of danntrolene on lever function<br>8)change of late potential between pre-dantrolene and post-dantrolene administration<br>9)evaluation of dantrolene efficacy by electrophysiological study