UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057701 |
|---|---|
| Receipt number | R000065712 |
| Scientific Title | Study on sarcopenia in young patients with congenital heart disease |
| Date of disclosure of the study information | 2025/04/28 |
| Last modified on | 2026/04/24 11:05:41 |
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Basic information
Public title
Study on sarcopenia in young patients with congenital heart disease
Acronym
Sarcopenia on adolescnets of CHD
Scientific Title
Study on sarcopenia in young patients with congenital heart disease
Scientific Title:Acronym
Sarcopenia on adolescnets of CHD
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the prevalence of sarcopenia in patients with congenital heart disease is high in childhood and adolescence.
Basic objectives2
Others
Basic objectives -Others
To determine whether the prevalence of sarcopenia in patients with congenital heart disease is high in childhood and adolescence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle strength measurement such as grip strength.
Body composition analysis by bio-impedance method.
Blood tests related to glucose and lipid metabolism and exercise.
Key secondary outcomes
Comprehensive quality of life assessment
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
| 10 | years-old | <= |
Age-upper limit
| 24 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Congenital heart disease patients (10-24 years old) treated at the University of Tsukuba Hospital and matched healthy volunteers
Key exclusion criteria
1) Cases in which the researcher is unable to perform the physical fitness test due to injury or other reasons
2) Cases in which the researcher determines that the participant is ineligible to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nozaki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Child Health
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-5635
nozaki.yoshihiro.wj@alumni.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Nozaki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Child Health
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
02-853-5635
Homepage URL
nozaki.yoshihiro.wj@alumni.tsukuba.ac.jp
Sponsor or person
Institute
Universitu of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba City
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2025 | Year | 04 | Month | 28 | 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
62
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
1. case-control study.
2. selection of study subjects: congenital heart disease patients (10-24 years old) treated at our facility from 2021 to March 2026 and matched healthy volunteers
3. evaluation items
Measurement of muscle strength such as grip strength
Body composition analysis using bioimpedance method
Activity assessment by questionnaire method
Comprehensive QOL evaluation
Blood tests related to glucose and lipid metabolism and exercise
Basic information on subjects: age, gender, height, and weight. 4.
4. recruitment method
A public call document will be prepared and recruitment will be conducted.
For disease groups, the study will be explained at the time of outpatient consultation and participation will be solicited.
Volunteers will be recruited by word of mouth from disease group participants.
Management information
Registered date
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065712
