UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032366 |
|---|---|
| Receipt number | R000036915 |
| Scientific Title | Multicenter case registration study of pulmonary hypertension with congenital heart disease |
| Date of disclosure of the study information | 2018/04/25 |
| Last modified on | 2021/09/18 09:18:47 |
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Basic information
Public title
Multicenter case registration study of pulmonary hypertension with congenital heart disease
Acronym
Multicenter case registration study of pulmonary hypertension with congenital heart disease
Scientific Title
Multicenter case registration study of pulmonary hypertension with congenital heart disease
Scientific Title:Acronym
Multicenter case registration study of pulmonary hypertension with congenital heart disease
Region
| Japan |
Condition
Condition
CHD-PAH (pulmonary arterial hypertension with congenital heart disease)
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the validity of treatment strategy in Japan and contribute to making the evidence-based guideline for CHD-PAH treatment
Basic objectives2
Others
Basic objectives -Others
To clarify the survival rate of CHD-PAH patients
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival rate of CHD-PAH patients
Key secondary outcomes
1. Status of medical treatment in CHD-PAH patients
2. Factors influencing outcome (survival rate)
3. Predictive factors of clinical worsening
4. Relationship between treatment drugs and outcome
5. Validity of treat and repair strategy
6. Similarity and difference of clinical course according to the shunt sites
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Any age
2. PH with any CHD who have no plan to have cardiac surgery or catheter intervention within 6 months
3. The diagnosis of PAH is made by cardiac catheterization. mean PAp>20mmHg or PVRI>=3Woodm2
4. Both cases with repaired or unrepaired shunt lesion
5. Cases with Fontan circulation or complex heart disease with major aortopulmonary collateral arteries included as specific patient groups
6. Cases participating another study
Key exclusion criteria
1. A case planned to have cardiac surgery or catheter intervention within 6 months
2. A case performed cardiac surgery or catheter intervention within 6 months
3. A case with extremely unstable status
4. A case without informed consent
5. A case judged as inappropriate by principal investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo
TEL
03-3353-8111
hagiwara.nobuhisa@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Pediatrics
Zip code
113-8510
Address
Yushima 1-5-45 Bunkyo-ku Tokyo
TEL
03-5803-5249
Homepage URL
tishii.ped@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review board of Tokyo Women's Medical University
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo
Tel
03-3353-8111
rinri.bm@twmu.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
東京女子医科大学（東京都）
東京医科歯科大学（東京都）
慶應義塾大学（東京都）
国際医療福祉大学（千葉県）
東京大学医学（東京都）
東邦大学医療センター大森病院（東京都）
静岡県立こども病院（静岡県）
長野県立こども病院（長野県）
三重大学医学部附属病院（三重県）
京都府立医科大学（京都府）
大阪大学（大阪府）
富山大学（富山県）
兵庫県立尼崎医療センター（兵庫県）
北海道大学（北海道大学）
神奈川県立こども医療センター（神奈川県）
福岡市立こども病院（福岡県）
国立成育医療研究センター（東京都）
東京都立小児総合医療センタ―（東京都）
榊原記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 25 | 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
| 2014 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational data:
Birth date
Gestational weeks
Birth weight
Gender
Height and weight
Pregnancy
NYHA functional class
Date of PAH diagnosis
Diagnosis of CHD
Cardiac repair
Type of PH
Chromosomal abnormality and underlying syndrome
Six minutes walk distance
QOL
Right heart catheterization data
Echocardiography data
Arterial oxygen saturation
Pulmonary function test data
Electrocardiography data
Blood test and biomarker
Treatment status of PAH
Management information
Registered date
| 2018 | Year | 04 | Month | 24 | Day |
Last modified on
| 2021 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036915
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
