UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051220 |
|---|---|
| Receipt number | R000058414 |
| Scientific Title | Clarification the mechanism of the right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/01 11:37:55 |
* 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
Clarification the mechanism of the right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease
Acronym
Clarification the mechanism of the right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease
Scientific Title
Clarification the mechanism of the right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease
Scientific Title:Acronym
Clarification the mechanism of the right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease
Region
| Japan |
Condition
Condition
Adult congenital heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to elucidate the mechanism of right ventricular failure related to chronic pulmonary regurgitation in adult patients with congenital heart disease by single nucleus transcriptome analysis using the human right ventricular myocardial tissues which are obtained intraoperably from the patients undergoing surgical pulmonary valve replacement for chronic pulmonary regurgitation.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of specific molecules associated with right ventricular failure related to chronic pulmonary regurgitation.
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with adult congenital heart disease scheduled for surgical pulmonary valve replacement for significant pulmonary regurgitation.
Key exclusion criteria
1.Patients who refused to participate in the study.
2.the investigator determined that the participant was inappropriate for the study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Terunobu |
| Middle name | |
| Last name | Fukuda |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
tefukuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Terunobu |
| Middle name | |
| Last name | Fukuda |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine
Zip code
650-0017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe-shi, Hyogo
TEL
078-382-5846
Homepage URL
tefukuda@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe 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
Secretariat of Medical Ethics Committee (Observational Research), Division of Research Ethics, Center for Clinical Research Promotion, Kobe University Hospital
Address
5-2, Kusunokucho 7-chome, Chuo, Kobe, Hyogo
Tel
0783825111
kansatsu@med.kobe-u.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
神戸大学医学部附属病院 (兵庫県)、兵庫県立こども病院 (兵庫県)、加古川中央市民病院 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058414
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
