UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029151 |
|---|---|
| Receipt number | R000033335 |
| Scientific Title | Home-Activity ICT-based Japan Ambulatory Blood Pressure Monitoring Prospective study |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2021/02/12 10:19:42 |
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Basic information
Public title
Home-Activity ICT-based Japan Ambulatory Blood Pressure Monitoring Prospective study
Acronym
HI-JAMP
Scientific Title
Home-Activity ICT-based Japan Ambulatory Blood Pressure Monitoring Prospective study
Scientific Title:Acronym
HI-JAMP
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed
1)to clarify the relationship between the individual risk of CV events and blood pressure obtained by multisensor ABPM
2)to clarify the relationship between individual facts in environment (temperature and atmospheric pressure) and lifestyle (activity) and blood pressure obtained by multisensor ABPM
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset of Major cardiovascular events*
*Major cardiovascular events; total death, cardiovascular death, sudden death, ischaemic heart disease (acute myocardial infarction, angina pectoris), cerebrovascular disease (cerebral infarction, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage), aortic dissection, and hospitalization by heart failure
Key secondary outcomes
1)New onset of atrial fibrillation, peripheral arterial disease, renal function degeneracy(chronic dialysis), diabetes mellitus, and gouty attack.
2)Relationship between CV events and blood pressure variability related to environment (temperature and atmospheric pressure) and lifestyle (activity)
3)Change of antihypertensive treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypertensive patients who receive treatment with antihypertensives
Key exclusion criteria
1. Patients who have history of erebrovascular disease (exclude asymptomatic and transient) within 6 months before consent.
2. Patients with chronic renal failure in haemodialysis
3. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease)
4. dementia
Target sample size
5000
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-shi, Tochigi, Japan 329-0498
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hoshide |
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-shi, Tochigi, Japan 329-0498
TEL
0285-58-7344
Homepage URL
hoshide@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Otsuka Medical Devices Co., Ltd.
A&D Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Foundation for Development of the Community
IRB Contact (For public release)
Organization
Ethics Review Committee, Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan 329-0498
Tel
0285-58-7550
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 他
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study consists of baseline and 5-year follow up.
24hr-ambulatory blood pressure monitoring and home blood pressure monitoring for 1-week will be conducted at baseline.
Management information
Registered date
| 2017 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033335
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
