UMIN-CTR Clinical Trial

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
Email	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
Email	miyoken@m.ehime-u.ac.jp

Sponsor
Institute	Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018304