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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015593
Receipt No. R000018118
Scientific Title The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Date of disclosure of the study information 2014/11/04
Last modified on 2018/05/07

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Basic information
Public title The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Acronym The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Scientific Title The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Scientific Title:Acronym The epidemiologic research of Fabry disease for hypertrophic cardiomyopathy in Yokohama.
Region
Japan

Condition
Condition Fabry disease
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the prevalence of Fabry disease in patients with a diagnosis of HCM (LVH more than 11mm), had examinations of ecocardiography in Yokohama University Hospital.
Basic objectives2 Others
Basic objectives -Others epidemiologic research
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Plasmma enzymatic activity of alpha-GAL A
2. Plasma globotriaosylsphingosine(Lyso-GB3)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We take blood sample of 5ml for the patients.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Petients participate in this trial on their own will.
Key exclusion criteria Patients can't participate in this trial on their own will, with dementia, et al.
Target sample size 480

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Yatsu
Organization Yokohama City University Graduate School of Medicine
Division name Medical Science and Cardiorenal Medicine
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL 045-787-2511
Email k-yatsu@be.wakwak.com

Public contact
Name of contact person
1st name
Middle name
Last name Minako Kagimoto
Organization Yokohama City University Graduate School of Medicine
Division name Medical Science and Cardiorenal Medicine
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL 045-787-2511
Homepage URL
Email minako@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 11 Month 04 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
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
2014 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 03 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018118

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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