UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061768 |
|---|---|
| Receipt number | R000070686 |
| Scientific Title | Clinical Utility of a 24-Hour Home Blood Pressure Management System Using a Novel Sleep Blood Pressure Device |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/02 15:16:50 |
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Basic information
Public title
Clinical Utility of a 24-Hour Home Blood Pressure Management System Using a Novel Sleep Blood Pressure Device
Acronym
DREAM-BP Study
Scientific Title
Clinical Utility of a 24-Hour Home Blood Pressure Management System Using a Novel Sleep Blood Pressure Device
Scientific Title:Acronym
DREAM-BP Study
Region
| Japan |
Condition
Condition
Having cardiovascular risk, or having a blood pressure in the high-normal range (systolic 120-129 mmHg and diastolic less than 80 mmHg) at the most recent health checkup (within the last 6 months)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeting adults with cardiovascular risk or with high-normal blood pressure (systolic 120-129 mmHg and diastolic less than 80 mmHg) at their most recent health checkup (within the last six months), this study aims to build and utilize a "24-hour home blood pressure management system." In this study, home blood pressure (morning, daytime, before bedtime, and during sleep) mesured by a portable hoseless sleep home blood pressure monitor (UA-1300BLE) will be monitored at a medical institution. The clinical usefulness and feasibility of implementing this system will be examined by evaluating blood pressure changes over the long term.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in blood pressure control status at 1 year from baseline
Key secondary outcomes
1) Changes in SBP, DBP and heart rate levels and variabilities over one year
2) Adherence rate for home blood pressure measurement (percentage of patients who meet the predetermined number of measurements per month)
3) Relationship between blood pressure control and organ damage and cardiovascular events
4) Relationship between blood pressure control status and lifestyle habits (today's body log information)
5) Adherence rate for daytime (workplace) blood pressure measurement
6) Association between the persistence rate of home blood pressure measurement and blood pressure control status
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all the following criteria:
1) Subjects with one or more cardiovascular risks* or blood pressure at the time of the most recent (within 6 months) blood pressure above high-normal (systolic 120-129 mmHg and diastolic less than 80 mmHg) *Cardiovascular risk: diabetes, hyperlipidemia, hypertension [hypertension under treatment or office blood pressure 130/80 mmHg or more), chronic kidney disease, atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia, current smoking habit, history of cerebrocardiovascular events (stroke, myocardial infarction, angina, aortic dissection, peripheral arterial disease, heart failure)
2) Upper arm circumference: 22.0 cm-32.0 cm
3) Subjects who agree to install a free health care app (A&D Connect Health) for blood pressure measurement and blood pressure data transmission
4) Those who can operate the above app
Key exclusion criteria
1)Those unfamiliar with the operation of smartphone
2) Smartphone users who do not have an A&D Connect compatible operating system
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
TEL
0285-58-7538
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University, Department of Digital Hypertension Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
A&D Company, Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan.
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院（栃木県）、鷲谷記念病院（栃木県）、岡崎ハートクリニック（東京都）、こみ内科クリニック（東京都）、南三陸病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational cohort study.
Participants are patients with cardiovascular risk factors or high-normal blood pressure who visit the participating institutions between April 2026 and March 2028 and meet the inclusion criteria.
The aim of this study is to develop and implement a "24-hour home blood pressure management system." Participants will be provided with a portable home blood pressure monitor (UA-1300BLE) and will measure their home blood pressure in the morning, daytime, before bedtime, and during sleep for 1-2 years (at least 7 days per month). The home blood pressure data will be monitored at the medical institution.
The clinical usefulness and feasibility of implementing this system will be evaluated by assessing long-term blood pressure changes and measurement adherence.
Management information
Registered date
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070686
