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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032366
Receipt No. R000036915
Scientific Title Japanese Registry to Encourage the Improvement of Outcome in CHD-PAH patients
Date of disclosure of the study information 2018/04/25
Last modified on 2018/04/24

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Basic information
Public title Japanese Registry to Encourage the Improvement of Outcome in CHD-PAH patients
Acronym J-EPOCH registry: Japanese Registry to Encourage the Improvement of Outcome in CHD-PAH patients
Scientific Title Japanese Registry to Encourage the Improvement of Outcome in CHD-PAH patients
Scientific Title:Acronym J-EPOCH registry: Japanese Registry to Encourage the Improvement of Outcome in CHD-PAH patients
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. prevalent case: a case already diagnosed as CHD-PAH
3. incident case: a case newly diagnosed as CHD-PAH
4. The diagnosis of PAH is basically made by cardiac catheterization.
5. The diagnosis by echocardiography is allowed according to the condition of each case.
6. Any type of congenital heart disease
7. Both cases with repaired or unrepaired shunt lesion
8. Continuous PAH over 3 months
9. A case registered to another clinical trial allowed
10. Cases with Fontan circulation or complex heart disease with major aortopulmonary collateral arteries included as specific patient groups
Key exclusion criteria 1. A case planned to have cardiac surgery or catheter intervention within 3 months
2. A case performed cardiac surgery or catheter intervention within 3 months
3. A case with extremely unstable status
4. A case without informed consent
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Nakanishi
Organization Tokyo Women's Medical University
Division name Department of Pediatric Cardiology
Zip code
Address Kawada-cho 8-1, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email pnakanis@hij.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Fukushima
Organization Keio University School of Medicine
Division name Department of Pediatrics
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email fuku-h@keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Pediatrics
Institute
Department

Funding Source
Organization Japan Research Promotion Society for Cardiovascular Diseases
Japanese Society of Pediatric Cardiology and Cardiac Surgery
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 ・東京女子医科大学病院(東京都)
・慶應義塾大学病院(東京都)
・東京大学医学部附属病院(東京都)
・東邦大学医療センター大森病院(東京都)
・東京医科歯科大学医学部附属病院(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)
・京都府立医科大学附属病院(京都府)
・大阪大学医学部附属病院(大阪府)
・兵庫県立尼崎総合医療センター(兵庫県)

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
Anticipated trial start date
2014 Year 10 Month 12 Day
Last follow-up date
2022 Year 12 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
2018 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.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


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