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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002966
Receipt No. R000003437
Scientific Title Longitudinal observation study on central blood pressure and cardiovascular outcome in Japanese patients treated with antihypertensive agents
Date of disclosure of the study information 2010/01/03
Last modified on 2014/07/19

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Basic information
Public title Longitudinal observation study on central blood pressure and cardiovascular outcome in Japanese patients treated with antihypertensive agents
Acronym Antihypertensives and Blood pressure of Central artery in Japan Follow-up Study (ABC-J II)
Scientific Title Longitudinal observation study on central blood pressure and cardiovascular outcome in Japanese patients treated with antihypertensive agents
Scientific Title:Acronym Antihypertensives and Blood pressure of Central artery in Japan Follow-up Study (ABC-J II)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between central blood pressure and cardiovascular events in treated hypertensive patients
Basic objectives2 Others
Basic objectives -Others To assess the relationship between central blood pressure at enrollment and cardiovascular outcome without specific intervention
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular events and death
Key secondary outcomes Central systolic blood pressure (cSBP)
Radial artery second systolic blood pressure (SBP2)
Radial augmentation Index (rAI)
delta SBP2 (SBP2-SBP)

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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Hypertensive patients on stable antihypertensive therapy (for three months or more).
2. Untreated hypertensive patients who will be treated with antihypertensive drugs
3. Treated hypertensive patients before changing antihypertensive medication

Key exclusion criteria Patients with extremely abnormal blood pressure (compared to usual office blood pressure or home blood pressure) during examination.

Patients with severe arrhythmia
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Shimada
Organization Shin-Oyama City Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5 Wakagi-cho, Oyama, Tochigi 323-0028 JAPAN
TEL 0285-21-3800
Email kazuyuki@hospital.oyama.tochigi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Miyashita
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498 JAPAN
TEL 0285-58-7343
Homepage URL
Email hrsm@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Omron Healthcare, 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) Nippon Shinyaku Co., Ltd.

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
2010 Year 01 Month 03 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
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Time courses of estimated central BP, antihypertensive therapy and occurrence of cardiovascular events are observed for 2 years or more.
Associations between central BP at enrollment and cardiovascular events as well as between change of therapy and central BP are assessed.

Management information
Registered date
2010 Year 01 Month 02 Day
Last modified on
2014 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003437

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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