UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015523 |
|---|---|
| Receipt number | R000017702 |
| Scientific Title | Prevalence of Fabry disease in Japanese population with left ventricular hypertrophy |
| Date of disclosure of the study information | 2014/10/26 |
| Last modified on | 2025/07/17 09:16:13 |
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Basic information
Public title
Prevalence of Fabry disease in Japanese population with left ventricular hypertrophy
Acronym
Fabry cardiomyopathy screening study
Scientific Title
Prevalence of Fabry disease in Japanese population with left ventricular hypertrophy
Scientific Title:Acronym
Fabry cardiomyopathy screening study
Region
| Japan |
Condition
Condition
left ventricular hypertrophy
Fabry disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prospective screening of Fabry disease in the patients with left ventricular hypertrophy; more than 12mm thickness of septum and/or posterior wall
Basic objectives2
Others
Basic objectives -Others
Evaluation of Lyso-Gb3 measurement for Fabry disease
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
enzymatic activity of alpha-galactsidase
Key secondary outcomes
measurement of Lyso-Gb3
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
left ventricular hypertrophy; more than 12mm thickness of septum and/or posterior wall
Key exclusion criteria
Patient with sarcomeric gene mutation
Patient with strongly affected hydrodynamics caused by severe valvular disease or congenital heart disease
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Akasaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
Address
1370-1 Okamoto, Kamakura city, Kanagawa 247-8533
TEL
0467-46-1717
akasaka-cba@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Akasaaka |
Organization
Shonan Kamakura General Hospital
Division name
Department of Cardiology
Zip code
Address
1370-1 Okamoto, Kamakura city, Kanagawa 247-8533
TEL
0467-46-1717
Homepage URL
akasaka-cba@umin.ac.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Genzyme Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 26 | 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 | 08 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
same as primary and secondary outcome
Management information
Registered date
| 2014 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017702
