UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054640 |
|---|---|
| Receipt number | R000062336 |
| Scientific Title | Genetic analysis research on inherited cardiovascular diseases |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2026/01/30 18:23:10 |
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Basic information
Public title
Genetic analysis research on inherited cardiovascular diseases
Acronym
Genetic analysis research on inherited cardiovascular diseases
Scientific Title
Genetic analysis research on inherited cardiovascular diseases
Scientific Title:Acronym
Genetic analysis research on inherited cardiovascular diseases
Region
| Japan |
Condition
Condition
Cardiomyopathy, arrhythmia, heart valve disease, and pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This research will conduct genetic analysis of genetic cardiovascular diseases, including cardiomyopathy, arrhythmia, valvular heart disease, and pulmonary hypertension, which are particularly common clinically, to identify mutations and identify abnormalities in disease-related proteins. In addition, the aim is to elucidate the pathology by examining clinical data and progress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of genes and investigation of clinical pathology of cardiomyopathy, arrhythmia, heart valve disease, and pulmonary hypertension.
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
| 1 | months-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From January 1, 1990, patients diagnosed with cardiomyopathy, arrhythmia, heart valve disease, and pulmonary hypertension, which are considered hereditary diseases, at the Department of Cardiovascular Medicine, Cardiovascular Surgery, and Pediatrics, Nagasaki University Hospital. , their blood relatives who have given their consent.
Key exclusion criteria
Cardiomyopathy, arrhythmia disease, heart valve disease, and pulmonary hypertension that are not considered to be hereditary.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Maemura |
Organization
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197288
maemura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawano |
Organization
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name
Department of Cardiovascular Medicine
Zip code
8528117
Address
1-7-1 Sakamoto, Nagasaki, Japan
TEL
0958197288
Homepage URL
hkawano@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki, Japan
Tel
0958197726
kenkyurinri@ml.nagasaki-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
| 2024 | Year | 06 | Month | 12 | 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
144
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to genetic analysis, we will consider general tests, electrocardiograms, echocardiograms, cardiac catheterization, myocardial biopsy pathological results, cardiac contrast MRI, myocardial scintigraphy, and other clinical tests and clinical progress.
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062336
