UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038369 |
|---|---|
| Receipt number | R000043726 |
| Scientific Title | Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2019/10/23 17:28:14 |
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Basic information
Public title
Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot
Acronym
The leg-positive pressure echocardiography for patients with repaired tetralogy of Fallot
Scientific Title
Non-invasive assessment of preload reserve using the leg-positive pressure maneuver in patients with repaired tetralogy of Fallot
Scientific Title:Acronym
The leg-positive pressure echocardiography for patients with repaired tetralogy of Fallot
Region
| Japan |
Condition
Condition
Tetralogy of Fallot
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the preload reserve of RV function and reveal its determining factor in patients with repaired TOF using LPP stress echocardiography.
Basic objectives2
Others
Basic objectives -Others
Hemodynamics
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
RV function and forward stroke volume at baseline and during LPP stress.
Key secondary outcomes
Standerd functional assessment, ventricular interaction between RV and left ventricle,left ventriclar diastolic dysfunction and BNP at baseline and during LPP stress.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
at rest and stress using the leg-positive pressure maneuver
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
repaired tetralogy of Fallot
Key exclusion criteria
(1) RV end-diastolic volume index exceeds 170 mL/m2 and/or RV end-systolic volume index exceeds 85 mL/m2 with severe PR (2) open-heart surgery within 6 months; (3) unstable heart failure; (4) unable to undergo LPP stress; (5) arrhythmia such as atrial fibrillation, second degree and third degree atrioventricular block and VVI pacing after pacemaker implantation; (6) orthopedic traumatic disease or active skin lesions in the lower limbs.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kobe University Hospital
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
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
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
0783825846
Homepage URL
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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 & Translational Research Center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
Tel
0783826669
chiken@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 | 10 | Month | 24 | 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
44
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
