UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037014 |
|---|---|
| Receipt number | R000042150 |
| Scientific Title | Examination of preload reserve in patients with atrial septal defect using positive leg pressure loading method |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/12/10 10:44:25 |
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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
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
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042150
