UMIN-CTR Clinical Trial

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