UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009450
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email anakamura-tuk@umin.ac.jp

Sponsor
Institute Tsukuba university
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010859

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.