UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029151
Receipt No. 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 2018/09/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular,Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan 329-0498
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hoshide
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular,Medicine, Department of Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan 329-0498
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 17 Day
Last follow-up date
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
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033335

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.