UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Title of the study (Brief title)	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

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	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	Yusuke Kobayashi
Organization	The Kobayashi Medical Clinic
Division name	Internal medicine
Address	2-2-2, Nakadaminami, Izumiku, Yokohama, Kanagawa
TEL	045-801-2551
Email	yusuke.kob@live.jp

Public contact
Name of contact person	Yusuke Kobayashi
Organization	The Kobayashi Medical Clinic
Division name	Internal medicine
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

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000017661