UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041419 |
|---|---|
| Receipt number | R000047279 |
| Scientific Title | Epidemiological and prognostic studies of isolated right ventricular hypoplasia |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2020/08/14 19:49:19 |
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Basic information
Public title
Epidemiological and prognostic studies of isolated right ventricular hypoplasia
Acronym
Epidemiological and prognostic studies of isolated right ventricular hypoplasia
Scientific Title
Epidemiological and prognostic studies of isolated right ventricular hypoplasia
Scientific Title:Acronym
Epidemiological and prognostic studies of isolated right ventricular hypoplasia
Region
| Japan |
Condition
Condition
isolated right ventricular hypoplasia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
epidemiological and prognostic studies
Basic objectives2
Others
Basic objectives -Others
natural history
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac event and death/heart transplantation
Key secondary outcomes
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
Patients with isolated right ventricular hypoplasia
Key exclusion criteria
Patients who cannot give consent to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Hirono |
Organization
University of Toyama
Division name
Department of Pediatrics, Faculty of Toyama
Zip code
9300194
Address
Sugitani 2630, Toyama city, Toyama
TEL
0764347313
khirono@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Hirono |
Organization
University of Toyama
Division name
Department of Pediatrics, Faculty of Toyama
Zip code
9300194
Address
Sugitani 2630, Toyama city, Toyama
TEL
0764347313
Homepage URL
khirono@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Japanese society of pediatric cardiology and cardiac surgery
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
Sugitani 2630, Toyama city, Toyama
Tel
0744347313
khirono@med.u-toyama.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
| 2020 | Year | 08 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Patient Background
2) Blood test
3) ECG findings
4) X-ray findings
5) Echocardiography
6) Cardiac catheterization
7) MRI scan findings
8) Nuclear Medicine Findings
9) Pathological findings
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2020 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
