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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015195
Receipt No. R000017661
Scientific Title Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Date of disclosure of the study information 2014/09/17
Last modified on 2016/09/21

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Basic information
Public title Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Acronym Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Scientific Title Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Scientific Title:Acronym Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Region
Japan

Condition
Condition Atherosclerotic disease
Classification by specialty
Medicine in general Cardiology Nephrology
Neurology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Influence of initial blood pressure decrease on sit-to-stand orthostatic test for cardiovascular outcomes
Basic objectives2 Others
Basic objectives -Others a prospective observational study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular events
All cause death
Key secondary outcomes Renal outcome
Hospitalization of heart failure
Fall and fracture

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hypertension
Diabetes mellitus
Dyslipidemia
Chronic kidney disease
Key exclusion criteria Atrial fibrillation
Neurodegenerative disease
Cerebral infarction
Cerebral hemorrhage
Cardiac infarction
Dialysis patient
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Kobayashi
Organization The Kobayashi Medical Clinic
Division name Internal medicine
Zip code
Address 2-2-2, Nakadaminami, Izumiku, Yokohama, Kanagawa
TEL 045-801-2551
Email yusuke.kob@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Kobayashi
Organization The Kobayashi Medical Clinic
Division name Internal medicine
Zip code
Address 2-2-2, Nakadaminami, Izumiku, Yokohama, Kanagawa
TEL 045-801-2551
Homepage URL
Email yusuke.kob@live.jp

Sponsor
Institute The Kobayashi Medical Clinic
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization The Kobayashi Medical Clinic
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 17 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Autonomic response on sit-to-stand orthostatic test
evaluate atherosclerosis using CAVI and carotid ultrasonography
observation of cardiovascular events

Management information
Registered date
2014 Year 09 Month 17 Day
Last modified on
2016 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017661


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