UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037884 |
|---|---|
| Receipt number | R000042038 |
| Scientific Title | The impact of preload change with head-up tilt testing on circulation evaluated by echocardiography |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2024/03/15 01:27:00 |
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Basic information
Public title
The impact of preload change with head-up tilt testing on circulation evaluated by echocardiography
Acronym
The impact of preload change with head-up tilt testing on circulation evaluated by echocardiography
Scientific Title
The impact of preload change with head-up tilt testing on circulation evaluated by echocardiography
Scientific Title:Acronym
The impact of preload change with head-up tilt testing on circulation evaluated by echocardiography
Region
| Japan |
Condition
Condition
Repaired tetralogy of Fallot
Post-chemotherapy
Type 1 diabetes mellitus
Healthy person
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Pediatrics |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of our study are to elucidate the mechanism of cardiac dysfunction and establish an index for early detection of cardiac dysfunction by changing the preload for patients after repaired tetralogy of Fallot with reduced diastolic function, patients with type 1 diabetes mellitus, and patient using tilt table.
Basic objectives2
Others
Basic objectives -Others
To examine and understand the changes due to capacitive load in IVPG and the left atrial function, which are the latest indicators of diastolic capacity, on healthy subjects using the tilt test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraventricular pressure difference during supine, tilt up and tilt down)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We performed echocardiography during head up and head down using tilt table for healthy subjects, patients with type 1 diabetes mellitus, repaired tetralogy of Fallot, and post-chemotherapy patients using the tilt table.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects, who are 15 years old or older and younger than 40 years old.
2. Subjects, who have received sufficient explanation for participation in this study, and with sufficient understanding, consent from the parental authority's free will and, if possible, subject's consent.
Key exclusion criteria
1. Advanced arrhythmia (3rd degree atrioventricular block, atrial fibrillation, atrial flutter, ventricular flutter)
2. Other patients, who are deemed inappropriate by the research director as subjects.
Of the above (1) target patients, (2) all the selection criteria are met and (3) none of the exclusion criteria are eligible.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takahashi |
Organization
Juntendo University
Division name
Pediatrics
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku, Tokyo
TEL
03-3813-3111
kentaka@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Hosono |
Organization
Juntendo University
Division name
Pediatrics
Zip code
113-8431
Address
3-1-3 Hongo,Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
yuadachi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kentaka@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
19-036
Org. issuing International ID_1
Juntendo University
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 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042038
| 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 |
