UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Morning Surge - Home Blood Pressure (J-HOP) study
Title of the study (Brief title)	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	Kazuomi Kario
Organization	Jichi Medical University, School of Medicine
Division name	Center of Excellence (COE) /Division of Cardiovascular Medicine
Address	Yakushiji 3311-1, Minamikawachi, Shimotsuke, Tochigi, Japan
TEL	0285-44-2111
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	Kimiyo Saito
Organization	J-HOP Study Center
Division name	Division of Cardiovascular Medicine, Jichi Medical University School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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