UMIN-CTR Clinical Trial

Basic information
Public title	Examination of preload reserve in patients with atrial septal defect using positive leg pressure loading method
Acronym	LPP-ASD
Scientific Title	Examination of preload reserve in patients with atrial septal defect using positive leg pressure loading method
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	By comparing the difference in preload capacity between the control and patients with atrial septal defect, we elucidate the hemodynamic characteristics, its compensation mechanism,and its failure mechanism in this disease.That will help heart failure treatment and appropriate surgery times for ASD.
Basic objectives2	Others
Basic objectives -Others	We compare stroke volume change by leg-positive pressure, before and after ASD occlusion and in the normal group.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We compare stroke volume change by leg-positive pressure, before and after ASD occlusion and in the normal group.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	We assess echocardiographic differences in stroke volume as the preload is increased in patients with atrial septal defects. Preload is to apply a pressure of 100 mmHg to both legs for 10 minutes at Dr. Medmer.
Interventions/Control_2	We assess echocardiographic differences in stroke volume as the preload is increased in patients with normal people. Preload is to apply a pressure of 100 mmHg to both legs for 10 minutes at Dr. Medmer.
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	The control was a group having no history of heart disease and no functional or structural abnormality. The disease group includes: Those have confirmed atrial septal defect by echocardiography, cardiac CT, or imaging such as cardiac MRI, 2 Those are hemodynamically stable
Key exclusion criteria	1.Hypertension (> 160/90 mmHg) and hypotension (<90/50 mmHg) 2.Having a history of acute other organ disease within 3 months 3.Patients with severe liver and kidney injury 4.Pregnant women 5.Patients who have or have a history of lower deep vein thrombosis 6.Patients who have injuries or skin problems at positive pressure area of lower extremity. The above was the exclusion criteria.
Target sample size	90

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, Kusunokicho, 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	None
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, Kusunokicho, Chuo-ku, Kobe City, Hyogo Prefecture
Tel	0783826669
Email	kenmatsu@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 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	2019 Year 05 Month 31 Day
Date of IRB	2019 Year 11 Month 05 Day
Anticipated trial start date	2019 Year 11 Month 05 Day
Last follow-up date	2020 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 10 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042150