UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009450 |
|---|---|
| Receipt number | R000010859 |
| Scientific Title | The evaluation of cardiopulmonary function and QOL for pediatric heart disease in the period of adolescence. |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2013/12/04 16:15:33 |
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Basic information
Public title
The evaluation of cardiopulmonary function and QOL
for pediatric heart disease in the period of adolescence.
Acronym
The evaluation of cardiopulmonary function and QOL
for pediatric heart disease in the period of adolescence.
Scientific Title
The evaluation of cardiopulmonary function and QOL
for pediatric heart disease in the period of adolescence.
Scientific Title:Acronym
The evaluation of cardiopulmonary function and QOL
for pediatric heart disease in the period of adolescence.
Region
| Japan |
Condition
Condition
congenital heart disease and acquired heart disease in childhood.
Classification by specialty
| Medicine in general | Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to detect potential cardiac dysfunction by cardiac echocardiography, cardiac MRI, and cardiopulmonary exercise test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation among ventricular volume, systolic function, energy loss of blood flow, and peak VO2.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
congenital heart disease and acquired heart disease
in childhood.
Interventions/Control_2
no cardiac anomaly and valvular disease in childhood.
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
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.subjects ride ergometer.
2.cardiac MRI without sedation.
Key exclusion criteria
1.NYHA>3
2.lifethreatning arrhythmia
3.patients are inadequate, decided by doctors.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Horigome |
Organization
Tsukuba university
Division name
Department of Child Health
Zip code
Address
1-1-1, Tennodai, Tsukuba, 305-8575, Japan
TEL
029-853-5635
hhorigom@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Nakamura |
Organization
Tsukuba university
Division name
Department of Child Health
Zip code
Address
1-1-1, Tennodai, Tsukuba, 305-8575, Japan
TEL
029-853-5635
Homepage URL
anakamura-tuk@umin.ac.jp
Sponsor or person
Institute
Tsukuba 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
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
| 2012 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 01 | Day |
Last modified on
| 2013 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010859
