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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016957
Receipt No. R000019682
Scientific Title Clinical significance of RH index in hypertensive patients
Date of disclosure of the study information 2015/03/28
Last modified on 2015/03/28

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Basic information
Public title Clinical significance of RH index in hypertensive patients
Acronym Endothelial dysfunction in essential hypertension
Scientific Title Clinical significance of RH index in hypertensive patients
Scientific Title:Acronym Endothelial dysfunction in essential hypertension
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Risk stratification of hypertensive patients by peripheral endothelial function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The presence and severity of coronary artery disease
Key secondary outcomes

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
85 years-old >=
Gender Male and Female
Key inclusion criteria hypertensive patinets with at least one coronary risk factor
Key exclusion criteria severe congestive heart failure
acute coronary syndrome
active inflammatory disease
past history of malignant disease
Target sample size 1300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamamoto Eiichiro
Organization Kumamoto University Hospital
Division name Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, Japan
TEL 81-96-373-5175
Email eyamamo@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yamamoto Eiichiro
Organization Kumamoto University Hospital
Division name Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, Japan
TEL 81-96-373-5175
Homepage URL
Email eyamamo@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kumamoto University Hospital
Institute
Department

Funding Source
Organization Department of Cardiovascular Medicine, Kumamoto University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 28 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
We demontrated the clinical significance of peripheral vascular function assesements in stable hypertensive patients for risk stratification of coronary artery disease.
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 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 01 Month 15 Day
Date analysis concluded
2015 Year 01 Month 15 Day

Other
Other related information Combining RH index to conventional coronary risk factors significantly improved AUC of ROC curve in predicting the presence of coronary artery disease.

Management information
Registered date
2015 Year 03 Month 28 Day
Last modified on
2015 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019682

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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