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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020611
Receipt No. R000023792
Scientific Title Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Date of disclosure of the study information 2016/01/18
Last modified on 2019/01/20

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Basic information
Public title Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Acronym Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Scientific Title Significance of sex hormone in the prognosis of patients with idiopathic ventricular fibrillation
Scientific Title:Acronym 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
1st name
Middle name
Last name Kusano Kengo
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Email kusanokengo@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kusano Kengo
Organization National Cerebral and Cardiovascular Center
Division name Cardiovascular medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results We could not find no relationship between the serum level of testosterone and occurence of ventricular fibrillation during 2 years follow-up period.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 09 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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