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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044397
Receipt No. R000049475
Scientific Title Analysis of human blood pressure control function
Date of disclosure of the study information 2021/06/02
Last modified on 2021/06/01

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Basic information
Public title Analysis of human blood pressure control function
Acronym Human blood pressure control function
Scientific Title Analysis of human blood pressure control function
Scientific Title:Acronym Human blood pressure control function
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Cardiology Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of human sympathetic baroreflex
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) Can the compressibility of disturbances to blood pressure be described? 2) Can the dynamic characteristics of the baroreflex system be described? 3) Can the effect of norepinephrine administration be described?
Key secondary outcomes 1) Comparison with patient group: Comparison of compression rate of disturbance to blood pressure between groups

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adults who cooperated in blood pressure control research between August 2001 and December 2001. Patients who were diagnosed with orthostatic hypotension at our hospital between November 1999 and December 2002 and underwent an autonomic nervous load test.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Fumiyasu
Middle name
Last name Yamasaki
Organization Kochi Medical School Hospital
Division name Clinical Laboratory
Zip code 783-8505
Address 185-1, kohasu, Oko-cho, Nankoku, Kochi
TEL 088-866-5811
Email yamasaki-f@kochi-u.ac.jp

Public contact
Name of contact person
1st name Fumiyasu
Middle name
Last name Yamasaki
Organization Kochi Medical School Hospital
Division name Clinical Laboratory
Zip code 783-8505
Address 185-1, kohasu, Oko-cho, Nankoku, Kochi
TEL 088-866-5811
Homepage URL
Email yamasaki-f@kochi-u.ac.jp

Sponsor
Institute Clinical Laboratory, Kochi Medical School Hospital
Institute
Department

Funding Source
Organization Kochi Medical School Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of Kochi Medical School
Address 185-1, kohasu, Oko-cho, Nankoku, Kochi
Tel 088-880-2180
Email rinri21@kochi-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 高知大学医学部附属病院(高知県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 02 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
2021 Year 04 Month 16 Day
Date of IRB
2021 Year 04 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 16 Day
Last follow-up date
2026 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The sympathetic baroreflex, which is a feedback system for stabilizing blood pressure, quickly stabilizes the decrease in blood pressure due to various daily disturbances, especially standing up. The functioning of this system allows humans to stand up, but it is unclear how strong and fast they control blood pressure. To elucidate these, it is necessary to analyze the gain and dynamic characteristics of the system, which opens the system by blocking the baroreceptor reflex system and fluctuates blood pressure and sympathetic nerves. In humans, it is possible to analyze by blocking the feedback system drug-wise, measuring disturbance, blood pressure, and norepinephrine levels, and changing each of them.
We conducted these studies and collected data in 1999-2002, and this time we will analyze the data and conduct observational studies for publication.
From these results, the function of the human blood pressure stabilization system (baroreceptor reflex system) can be quantitatively evaluated, and a new index useful for the diagnosis and treatment of blood pressure fluctuation, particularly orthostatic hypotension, can be provided.

Method:
An observational study will be conducted to analyze the following data collected in 1999-2002.

analysis method:
1) Equilibrium diagram of arterial pressure and norepinephrine level
2) Dynamic reaction analysis using random standing load
3) Effect of intravenous norepinephrine on blood pressure over time
The blood pressure control function of humans is analyzed using the above three methods.
In order to open the baroreceptor reflex system, parasympathetic blockade was performed by intravenous atropine (0.04 mg / kg) and sympathetic blockade was performed by intravenous infusion of trimetaphan (0.1 mg / kg / min).

Management information
Registered date
2021 Year 06 Month 01 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049475

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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