UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Title of the study (Brief title)	Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Region	Japan

Condition
Condition	idiopathic ventricular fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relation between sex hormone and clinical characteristics in patients with idiopathic ventricular fibrillation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between sex hormone (testosterone) and clinical characteristics in idiopathic ventricular fibrillation
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with idiopathic ventricular fibrillation (Brugada syndrome, early repolarizaton syndrome, idiopathic ventricular fibrillation of unknown cause) in the National Cerebral and Cardiovascular Center)
Key exclusion criteria	none
Target sample size	40

Research contact person
Name of lead principal investigator	Kusano Kengo
Organization	National Cerebral and Cardiovascular Center
Division name	Cardiovascular medicine
Address	5-7-1 Fujishiro-dai, Suita, Osaka
TEL	06-6833-5012
Email	kusanokengo@hotmail.com

Public contact
Name of contact person	Kusano Kengo
Organization	National Cerebral and Cardiovascular Center
Division name	Cardiovascular medicine
Address	5-7-1 Fujishiro-dai, Suita, Osaka
TEL	06-6833-5012
Homepage URL
Email	kusanokengo@hotmail.com

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Intramural research funds (22-1-2) for cardiovascular disease from National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 27 Day
Anticipated trial start date	2016 Year 01 Month 18 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We could not find no relationship between the serum level of testosterone and occurence of ventricular fibrillation during 2 years follow-up period.
Other related information	This study is a single center, prospective and retrospective study. We are going to take blood samples and evaluate sex hormone (testosterone, etc) in patients with idiopathic ventricular fibrillation, who have been admitted to the National Cerebral and Cardiovascular Center since January, 2016.

Management information
Registered date	2016 Year 01 Month 18 Day
Last modified on	2019 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023792