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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009187
Receipt No. R000010699
Scientific Title Usefulness of a new method for evaluating autonomic nervous system function
Date of disclosure of the study information 2012/10/29
Last modified on 2013/05/30

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Basic information
Public title Usefulness of a new method for evaluating autonomic nervous system function
Acronym Usefulness of a new method for evaluating autonomic nervous system function
Scientific Title Usefulness of a new method for evaluating autonomic nervous system function
Scientific Title:Acronym Usefulness of a new method for evaluating autonomic nervous system function
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulnes of a new method for evaluating autonomic nervous system function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes CVRR L/H
ABPM
CAVI
Carotid Ultrasound Examination
ABI/PWV
blood chemical values
complete blood cell counts
urine test
apelin
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with atherosclerosis
Key exclusion criteria Patients diagnosed with inappropriate
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatshuo Hashimoto
Organization Yokohama City University
Division name Nephology/Hypertension
Zip code
Address 9-3 fukuura kanazawaku yokohamasi
TEL 0457872635
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatshuo Hashimoto
Organization Yokohama City University
Division name Nephology/Hypertension
Zip code
Address 9-3 fukuura kanazawaku yokohamasi
TEL 0457872635
Homepage URL
Email

Sponsor
Institute Nephology/Hypertension
Institute
Department

Funding Source
Organization Nephology/Hypertension
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor saiseikai yokohamasinannbu hospital
Kobayasi Clinic
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 横浜市立大学附属病院(神奈川県)、小林内科クリニック(神奈川県)
恩賜財団済生会横浜市南部病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 29 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyze the relationship between the test item and autonomic function in patients with arteriosclerosis

Management information
Registered date
2012 Year 10 Month 25 Day
Last modified on
2013 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010699

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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