UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044397 |
|---|---|
| Receipt number | 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 18:08:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yamasaki-f@kochi-u.ac.jp
Sponsor or person
Institute
Clinical Laboratory, Kochi Medical School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
|---|---|
| Registered date | File name |
