UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002966 |
|---|---|
| Receipt number | 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 10:34:09 |
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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
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
hrsm@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003437
