UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043900