UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058026 |
|---|---|
| Receipt number | R000066325 |
| Scientific Title | Assessment of health guidance for hypertension based on genetic information |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/12/08 11:09:06 |
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Basic information
Public title
Assessment of health guidance for hypertension based on genetic information
Acronym
Order-made health guidance for hypertension
Scientific Title
Assessment of health guidance for hypertension based on genetic information
Scientific Title:Acronym
Order-made health guidance for hypertension
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will examine the influence of differences in genetic polymorphisms related to hypertension on the effectiveness of post-health guidance for hypertension, and establish a tailored health guidance method that takes genetic polymorphisms into consideration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure reduction after health guidance due to hypertension-related gene polymorphisms
Key secondary outcomes
Changes in salt intake, Na/K ratio, body weight, etc. after health guidance for each hypertension-related gene polymorphism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health guidance for people with high blood pressure and high blood pressure
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Employees belonging to the NTT Group who have already received Illumina's Infinium Asian Screening Array and have genetic polymorphism data with their consent.
2 Persons whose blood pressure at the time of medical examination and home blood pressure are higher than high blood pressure, or who have grade I hypertension, based on the 2019 Hypertension Treatment Guidelines
3 Persons who are over 40 years old and under 65 years old at the time of obtaining consent
4 Persons who have given written consent to participate in the research
Key exclusion criteria
1 Persons who are pregnant or breastfeeding
2 Persons with a serious illness that requires immediate treatment
3 Other persons deemed unsuitable by the research director, co-investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kamide |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Health Promotion Science, Division of Health Sciences
Zip code
5650871
Address
1-7, Yamadaoka, Suita city, Osaka
TEL
81-6-6879-2551
kamide@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Kamide |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Health Promotion Science, Division of Health Sciences
Zip code
5650871
Address
1-7, Yamadaoka, Suita city, Osaka
TEL
81-6-6879-2551
Homepage URL
kamide@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Kei Kamide
Funding Source
Organization
private company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NTT precision medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital
Address
2-2 YAMADAOKA, SUITA CITY, OSAKA
Tel
81-6-6879-5111
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | 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
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066325
