UMIN-CTR Clinical Trial

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
Email	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
Email	sakurasoma1209@yahoo.co.jp

Sponsor
Institute	kanazawa university hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045340