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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name