UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038542 |
|---|---|
| Receipt number | R000043900 |
| Scientific Title | Retrospective observational study on right heart function before and after atrial septal defect closure |
| Date of disclosure of the study information | 2019/11/13 |
| Last modified on | 2021/05/13 09:37:04 |
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Basic information
Public title
Retrospective observational study on right heart function before and after atrial septal defect closure
Acronym
Right heart function in patients with atrial septal defect
Scientific Title
Retrospective observational study on right heart function before and after atrial septal defect closure
Scientific Title:Acronym
Right heart function in patients with atrial septal defect
Region
| Japan |
Condition
Condition
atrial septal defect
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify patients with heart failure symptoms after atrial septal defect closure, retrospectively from preoperative clinical and imaging data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference between TRPG, TAPSE and Simplified RVCPI before and after ASD closure.
Key secondary outcomes
The patients are defined as the 'symptom-remaining group' when they have the heart failure symptoms in the chronic stage after ASD closure, and as 'symptom disappearance group' ,when no symptoms.
The secondary outcome is the difference between sRVCPI and RV-PA coupling in these two groups
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients whose atrial septal defect has been confirmed by echocardiography, cardiac CT, or cardiac MRI imaging are considered as a group of patients with atrial septal defect(2) Patients who have undergone atrial septal defect closure in our hospital registered in the database
Key exclusion criteria
nothing special
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | kensuke |
| Middle name | |
| Last name | matsumoto |
Organization
Kobe University hospital
Division name
cardiovascular medicine
Zip code
6500017
Address
7-5-2 Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL
0783825846
kenmatsu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | kensuke |
| Middle name | |
| Last name | matsumoto |
Organization
Kobe University hospital
Division name
cardiovascular medicine
Zip code
6500017
Address
7-5-2 Kashiwagicho, Chuo-ku, Kobe City, Hyogo Prefecture
TEL
0783825846
Homepage URL
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
no
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
Kobe University Hospital clinical and translational research center
Address
7-5-2 Kashiwagicho, Chuo-ku, Kobe City, Hyogo Prefecture
Tel
0783826669
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
140
Results
PVRI and PA-RV coupling may be useful as indicators to predict the presence of residual symptoms after ASD closure.
Results date posted
| 2021 | Year | 05 | Month | 13 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For patients who have undergone atrial septal defect closure in our hospital, right heart function evaluation had been performed before and after closure, and cases with remaining heart failure may be identified retrospectively from preoperative clinical and image data.
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043900
