UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051166 |
|---|---|
| Receipt number | R000058356 |
| Scientific Title | Pilot study to improve the rate of achievement of antihypertensive goals using a high usability blood pressure monitoring system |
| Date of disclosure of the study information | 2023/05/29 |
| Last modified on | 2024/05/25 18:29:10 |
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Basic information
Public title
Pilot study to improve the rate of achievement of antihypertensive goals using a high usability blood pressure monitoring system
Acronym
Research to Improve the Rate of Achievement of Antihypertensive Goals with a High Usability Blood Pressure Monitoring System
Scientific Title
Pilot study to improve the rate of achievement of antihypertensive goals using a high usability blood pressure monitoring system
Scientific Title:Acronym
Research to Improve the Rate of Achievement of Antihypertensive Goals with a High Usability Blood Pressure Monitoring System
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pilot study to test the hypothesis that the achievement rate of the antihypertensive target in the Guidelines for the Treatment of Hypertension 2019 (JSH2019), which remains around 50%, can be improved by using an innovative high-usability blood pressure monitoring system to be jointly developed by Omron Healthcare and International University of Health and Welfare
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre- and post-study changes in the rate of achievement of antihypertensive goals in JSH2019
Key secondary outcomes
Average home blood pressure value and change
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
| Device,equipment |
Interventions/Control_1
High usability blood pressure monitoring system
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Have home blood pressure data for the past 30 days
Key exclusion criteria
Severely hypertensive patients, have malignant tumors, have disease with prognosis within 1 year
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | TAKUYA |
| Middle name | |
| Last name | KISHI |
Organization
International University of Health and Welfare
Division name
Department of Graduate School of Medicine (Cardiology)
Zip code
831-8501
Address
137-1 Enokizu, Okawa City, Fukuoka
TEL
0944-89-2000
tkishi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | TAKUYA |
| Middle name | |
| Last name | KISHI |
Organization
International University of Health and Welfare
Division name
Department of Graduate School of Medicine (Cardiology)
Zip code
831-8501
Address
37-1 Enokizu, Okawa City, Fukuoka
TEL
0944-89-2000
Homepage URL
tkishi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
International University of Health and Welfare
Tel
0944-89-2000
tkishi@iuhw.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
| 2023 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41440-023-01510-9
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41440-023-01510-9
Number of participants that the trial has enrolled
19
Results
Nineteen patients with hypertension used HMS for six months. The percentage of patients achieving their antihypertensive goal increased from 16% to 37%. Mean home systolic BP decreased. The increase in number of home BP measurements was significantly associated with the amount of homed systolic BP reduction in men. In conclusion, HMS without educational content may be an adjunct to hypertension treatment.
Results date posted
| 2024 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058356
