UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015821 |
|---|---|
| Receipt number | R000018304 |
| Scientific Title | Prevalence of Fabry disease among patients with hypertrophic cardiomyopathy, dilated cardiomyopathy and left ventricular hypertrophy with proteinuria |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2019/06/06 18:15:01 |
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Basic information
Public title
Prevalence of Fabry disease among patients with hypertrophic cardiomyopathy, dilated cardiomyopathy and left ventricular hypertrophy with proteinuria
Acronym
Prevalence of Fabry disease
Scientific Title
Prevalence of Fabry disease among patients with hypertrophic cardiomyopathy, dilated cardiomyopathy and left ventricular hypertrophy with proteinuria
Scientific Title:Acronym
Prevalence of Fabry disease
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the prevalence of Fabry disease
Basic objectives2
Others
Basic objectives -Others
Diagnosis of Fabry disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of Fabry disease
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Participants are inpatients and outpatients of the Ehime University Hospital.
Patients with hypertrophic cardiomyopathy, dilated cardiomyopathy and left ventricular hypertrophy(septal thickness or posterior wall thickness is 13 mm and over) with proteinuria(dipstick proteinuria of 1+ and over).
Patients gave written informed consent.
Key exclusion criteria
Patients judged inappropriate for the study by their physicians.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Okura |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
Address
Toon City, Ehime, 791-0295, Japan
TEL
089-960-5303
okura@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Miyoshi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
Address
Toon City, Ehime, 791-0295, Japan
TEL
089-960-5303
Homepage URL
miyoken@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 12 | Month | 03 | 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 | 11 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Screening of Alpha-galactosidase A activity :Alpha-galactosidase A activity is determined using blood spots on filter paper. When the activity is reduced, the screeng test is repeated.
Definite diagnosis: When Alpha-galactosidase A activity is reduced in repeated screening, genetic diagnosis of Fabry disease is perfomed.
Management information
Registered date
| 2014 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018304
