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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038542
Receipt No. 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 2019/11/11

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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
Email 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
Email kenmatsu@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

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
Email 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 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 11 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 24 Day
Last follow-up date
2019 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
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043900

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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