UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047347 |
|---|---|
| Receipt number | R000054002 |
| Scientific Title | High-risk screening for propionic acidemia, fatty acid metabolism disorders, Fabry disease and mitochondrial disease in patients with hypertrophic cardiomyopathy / dilated cardiomyopathy |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/03/31 20:24:49 |
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Basic information
Public title
Detection of propionic acidemia, fatty acid metabolism disorders, Fabry disease and mitochondrial disease in patients with hypertrophic cardiomyopathy / dilated cardiomyopathy
Acronym
Detection of metabolic disorders in patients with hypertrophic cardiomyopathy / dilated cardiomyopathy
Scientific Title
High-risk screening for propionic acidemia, fatty acid metabolism disorders, Fabry disease and mitochondrial disease in patients with hypertrophic cardiomyopathy / dilated cardiomyopathy
Scientific Title:Acronym
High-risk screening for metabolic disorders in patients with hypertrophic cardiomyopathy and dilated cardiomyopathy
Region
| Japan |
Condition
Condition
hypertrophic cardiomyopathy / dilated cardiomyopathy
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
High-risk screening in patients with hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM) diagnoses propionic acidemia, fatty acid metabolism disorders, Fabry disease or mitochondrial disease.
Basic objectives2
Others
Basic objectives -Others
High-risk screening in patients with hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM) will clarify the prevalence of propionic acidemia, fatty acid metabolism disorders, Fabry disease or mitochondrial disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of propionic acidemia, fatty acid metabolism disorders, Fabry disease, mitochondrial disease
Key secondary outcomes
search for clinical characteristics of metabolic disorders
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with hypertrophic cardiomyopathy or dilated cardiomyopathy of unknown cause
Key exclusion criteria
Patients with hypertrophic cardiomyopathy or dilated cardiomyopathy whose etiology is already clear
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Noma |
Organization
Kagawa university
Division name
Faculty of medicine, Department of cardiorenal cerebrovascular medicine
Zip code
761-0793
Address
1750-1, miki, kita, kagawa
TEL
087-891-2150
noma.takahisa.ps@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahisa |
| Middle name | |
| Last name | Noma |
Organization
Kagawa university
Division name
Faculty of medicine, Department of cardiorenal cerebrovascular medicine
Zip code
761-0793
Address
1750-1, miki, kita, kagawa
TEL
087-891-2150
Homepage URL
noma.takahisa.ps@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
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
kagawa university
Address
1750-1, miki, kita, kagawa
Tel
087-898-5111
kenkyushien@kagawa-u.ac.jp
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
| 2022 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Joint research at Kagawa University, Kochi University, Chiba Children's Hospital, Juntendo University
Perform blood acylcarnitine analysis, urinary organic acid analysis, mitochondrial DNA gene analysis
Management information
Registered date
| 2022 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054002
