UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039755 |
|---|---|
| Receipt number | R000045340 |
| Scientific Title | The examination about the association between Adipocyte Fatty Acid Binding Protein (A-FABP) and the sympathetic nerve activity |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/10 13:15:21 |
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Basic information
Public title
The examination about the association between Adipocyte Fatty Acid Binding Protein (A-FABP) and the sympathetic nerve activity
Acronym
The examination about the association between Adipocyte Fatty Acid Binding Protein (A-FABP) and the sympathetic nerve activity
Scientific Title
The examination about the association between Adipocyte Fatty Acid Binding Protein (A-FABP) and the sympathetic nerve activity
Scientific Title:Acronym
The examination about the association between Adipocyte Fatty Acid Binding Protein (A-FABP) and the sympathetic nerve activity
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that enhanced sympathetic nerve activity is related to the cardiovascular disease including the heart failure, therefore we thought sympathetic nerve activity is one of the important treatment targets. However, it is difficult to evaluate the sympathetic nerve activity in human.
In late years, it was reported that A-FABP was related to the change of the blood catecholamine level by the exercise. A-FABP was attracted attention for an index of the sympathetic nerve activity. However, it is no report of the association between A-FABP and MSNA. Therefore, in this study, we examined about the association A-FABP and MSNA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the change of MSNA (multiunit)
Key secondary outcomes
Blood test (blood catecholamine 3 compartmentation (adrenalin, noradrenaline, dopamine), FABP4), blood pressure, the pulse rate
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who had a diagnosis of high blood pressure based on hypertensive treatment guidelines 2019
The patients that secondary high blood pressure was denied with hyperthyroidism, phaeochromocytoma, renal artery stenosis
The patients that an agreement is provided in a document about participation of this study
Key exclusion criteria
The patient that the agreement with the document is not provided
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Takamura |
Organization
kanazawa university hospital
Division name
Circulatory organ internal medicine
Zip code
920-8641
Address
13-1, Takara machi, Kanazawa city, Ishikawa prefecture
TEL
076-265-2000
sakurasoma1209@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hisayosi |
| Middle name | |
| Last name | Murai |
Organization
kanazawa university hospital
Division name
Circulatory organ internal medicine
Zip code
920-8641
Address
13-1, Takara machi, Kanazawa city, Ishikawa prefecture
TEL
076-265-2000
Homepage URL
sakurasoma1209@yahoo.co.jp
Sponsor or person
Institute
kanazawa university hospital
Institute
Department
Personal name
Funding Source
Organization
Otsuka medical device company
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
kanazawa university hospital
Address
13-1, Takara machi, Kanazawa city, Ishikawa prefecture
Tel
076-265-2000
sakurasoma1209@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
| 2020 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045340
| 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 |
