UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective observational study of preload reserve in patients with atrial septal defect by noninvasive leg-positive pressure stress echocardiography
Acronym	LPP-ASD
Scientific Title	Retrospective observational study of preload reserve in patients with atrial septal defect by noninvasive leg-positive pressure stress echocardiography
Scientific Title:Acronym	LPP-ASD
Region	Japan

Condition
Condition	atrial septal defect
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare how the response to leg-positive pressure stress differs between normal controls and patients with atrial septal defect.
Basic objectives2	Others
Basic objectives -Others	To clarify the hemodynamic characteristics of atrial septal defect by examining how the response to leg-positive pressure stress changes 6 months after atrial septal defect closure in patients with atrial septal defect.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is the difference in stroke volume between resting and stressed leg-positive pressure before closure (up to 3 days) between normal controls and patients with atrial septal defect.
Key secondary outcomes	Secondary outcomes: (1) Difference in stroke volume between rest and load before (within 3 days) and 6 months after atrial septal defect closure (2) Normal control and patients with atrial septal defect the difference between the stroke volume at rest and at load 6 months after atrial septal defect closure.

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	Patients with atrial septal defect is confirmed by imaging tests such as echocardiography, cardiac CT, or cardiac MRI, and is hemodynamically stable (NYHA I-III) among patients undergoing atrial septal defect closure at our hospital. Patients were selected.
Key exclusion criteria	1. Poor control patients with hypertension (160/90 mmHg) or hypotension (90/50 mmHg) 2. Those with a history of acute other organ diseases such as pulmonary embolus within 3 months 3. NYHA Patients with congestive heart failure with cardiac function IV degree 4. Patients with severe hepatorenal failure 5. Pregnant woman 6. Patients with or have a history of deep vein thrombosis 7. Patients with trauma or skin diseases in the leg-positive pressure area of the lower leg
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Suzuki Middle name Last name Makiko
Organization	Kobe University Hospital
Division name	cardiovascular medicine
Zip code	650-0011
Address	Kusunokicho7-5-2Chuo-ku Kobe-shi
TEL	+819051530817
Email	suzukimakko@yahoo.co.jp

Public contact
Name of contact person	1st name Makiko Middle name Last name Suzuki
Organization	Kobe University Hospital
Division name	cardiovascular medicine
Zip code	650-0011
Address	Kusunokicho7-5-2 Chuo-ku Kobe-shi
TEL	+819051530817
Homepage URL
Email	suzukimakko@yahoo.co.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

Funding Source
Organization	Nothing
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	Kusunokicho7-5-2Chuo-ku Kobe-shi Hyogo Prefecture
Tel	0783826669
Email	suzukimakko@yahoo.co.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	2021 Year 09 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	Terminated
Date of protocol fixation	2021 Year 01 Month 10 Day
Date of IRB	2021 Year 02 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2021 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2021 Year 01 Month 26 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049232