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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000894
Receipt No. R000001070
Scientific Title Japan Morning Surge - Home Blood Pressure (J-HOP) study
Date of disclosure of the study information 2007/11/15
Last modified on 2017/01/27

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Basic information
Public title Japan Morning Surge - Home Blood Pressure (J-HOP) study
Acronym J-HOP Study
Scientific Title Japan Morning Surge - Home Blood Pressure (J-HOP) study
Scientific Title:Acronym J-HOP Study
Region
Japan

Condition
Condition Subjects with any cardiovascular risk factors
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of prognostic value of home blood pressure in patients with any cardiovascular risk factors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total death, Cardiovascular Death, Sudden Death, Cardiovascular event, Stroke, Congestive Heart Failure
Key secondary outcomes Peripheral Arterial Disease, Dialysis, Atrial fibrillation, New Onset Diabetes, New Onset Hypertension

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetes or Impaired glucose tolerance, Hyperlipidemia, Hypertension, Current Smoker, Renal Disease, Atrial Fibrillation, Metabolic Syndrome, Chronic Pulmonary Disease, Sleep Apnea Syndrome
Key exclusion criteria 1)Recent Ischemic Heart Disease, Cerebrovascular Disease, Aortic Dissection, Peripheral Arterial Disease.
2)Chronic Hemodialysis.
3)Chronic illness such as cancer and/or collagen disease.
4)Inelgible informed consent.
Target sample size 4000

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 Center of Excellence (COE) /Division of Cardiovascular Medicine
Zip code
Address Yakushiji 3311-1, Minamikawachi, Shimotsuke, Tochigi, Japan
TEL 0285-44-2111
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimiyo Saito
Organization J-HOP Study Center
Division name Division of Cardiovascular Medicine, Jichi Medical University School of Medicine
Zip code
Address Yakushiji 3311-1, Minamikawachi, Shimotsuke, Tochigi, Japan
TEL 0285-44-2130
Homepage URL
Email saikimi@jichi.ac.jp

Sponsor
Institute Center of Excellence (COE) Program / Division of Cardiovascular Medicine, Jichi Medical University
Institute
Department

Funding Source
Organization Center of Excellence Program/Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2007 Year 11 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 Completed
Date of protocol fixation
2005 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective Study

Management information
Registered date
2007 Year 11 Month 15 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001070

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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