UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054509 |
|---|---|
| Receipt number | R000062280 |
| Scientific Title | Validation study of a program to prevent severe hypertension 2 |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2025/06/17 10:13:01 |
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Basic information
Public title
Validation study of a program to prevent severe hypertension 2
Acronym
Validation study of a program to prevent severe hypertension 2
Scientific Title
Validation study of a program to prevent severe hypertension 2
Scientific Title:Acronym
Validation study of a program to prevent severe hypertension 2
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether the program to prevent severe hypertension can achieve target blood pressure reduction in a short period of time.
To test whether three types of arrhythmia (bradycardia, tachycardia, and atrial fibrillation) can be detected early and lead to introduction to a medical institution by lending portable electrocardiographs to people who have arrhythmia found during a health checkup but have not received treatment, or who experience irregular pulse waves when measuring blood pressure at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate of home blood pressure less than 135/85 mmHg
Participation rate
Completion rate
Key secondary outcomes
Home blood pressure (e.g., amount of blood pressure reduction from baseline)
Percentage of patients receiving online medical care
Rate of continuation of home blood pressure measurement
Percentage of patients who continue to take their medications
Improvement rate of event risk(Myocardial infarction, cerebral hemorrhage, cerebral infarction, aortic aneurysm/dissection, and heart failure)
Detect three types of suspected arrhythmia (bradycardia, tachycardia, and atrial fibrillation)
Number of introduction to medical institutions on detection of arrhythmia
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
| Medicine | Device,equipment |
Interventions/Control_1
The subjects have an initial online consultation and take the antihypertensive medication prescribed at the time of the consultation. The subjects measure blood pressure at home with a distributed brachial sphygmomanometer and send the data for 3 months. During this period, the subjects receive an online consultation every 2 weeks. Thereafter, home blood pressure is measured and the status of visits to the clinic is monitored for a follow-up period of 12 months.
Record electrocardiograms with a portable electrocardiograph lent to people who have detected an arrhythmia during a health checkup but have not received treatment, or who experience irregular pulse waves when measuring their blood pressure at home. When three types of arrhythmia (bradycardia, tachycardia, and atrial fibrillation)are detected, a medical information report is created and the patient is encouraged to consult a doctor.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Members of the health insurance association of companies agreeing with this study(non-family)
3.Persons who are at high risk of developing one of the following five events in the next three years: myocardial infarction or cerebral hemorrhage or stroke or aortic aneurysm/dissection or heart failure (Persons who meet either (1)or (2) or (3)below)
(1)Persons who are in the top 5% at risk of developing the event and whose systolic blood pressure is 140 mmHg or higher or diastolic blood pressure is 90 mmHg or higher according to the results of the most recent medical checkup.
(2)Persons who are in the top 10% at risk of developing the event and whose systolic blood pressure is 160 mmHg or higher or diastolic blood pressure is 100 mmHg or higher according to the results of the most recent medical checkup.
(3)Persons with systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher as a result of the most recent medical checkup and who are at "high risk" for cerebrovascular disease based on hypertension treatment guidelines.
4.Regardless of the condition in (3), hypertensive patients who meet the conditions set by the companies and health insurance associations participating in this study.
5.Persons who can participate in the online conference via own smartphone, tablet, or computer.
Key exclusion criteria
1.Persons who are participating in other health programs such as specific health guidance and serious illness prevention programs conducted by Health Insurance Association
2.Persons who are participating in other clinical trials
3.Persons who have already experienced the onset of the following events
Event onset: myocardial infarction, cerebral hemorrhage, stroke, aortic aneurysm/dissection, heart failure
4.Persons with persistent atrial fibrillation
5.Secondary hypertension (excluding idiopathic aldosteronism)
6.Persons with other serious diseases
7.Persons who are pregnant or breastfeeding
8.Persons who are deemed inappropriate by the industrial physician or industrial nurse at their company or office
9.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
General Incorporated Association
telemedEASE
Division name
Representative Director
Zip code
102-0083
Address
2F Kojimachi New Yahiko Building, 2-30, Kojimachi 6-chome, Chiyoda-ku, Tokyo
TEL
050-3528-8158
supportjyatabe@telemedease.org
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
General Incorporated Association telemedEASE
Division name
Representative Director
Zip code
102-0083
Address
2F Kojimachi New Yahiko Building, 2-30, Kojimachi 6-chome, Chiyoda-ku, Tokyo
TEL
050-3528-8158
Homepage URL
supportjyatabe@telemedease.org
Sponsor or person
Institute
General Incorporated Association
telemedEASE
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2024 | Year | 05 | Month | 30 | 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
32
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062280
