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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000014604
Receipt No. R000016993
Scientific Title Evaluation of Cardiovascular Event Risk in Hemodialysis Patients
Date of disclosure of the study information 2014/07/21
Last modified on 2015/01/25

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Basic information
Public title Evaluation of Cardiovascular Event Risk in Hemodialysis Patients
Acronym CV risk in hemodialysis
Scientific Title Evaluation of Cardiovascular Event Risk in Hemodialysis Patients
Scientific Title:Acronym CV risk in hemodialysis
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of cardiovascular risk in hemodialysis patients
Basic objectives2 Others
Basic objectives -Others registry, observational study
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes all-cause death
Key secondary outcomes all-cause death, non-fatal myocardial infarction, apoplexy, heart failure

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 dialysis patients
Key exclusion criteria none
Target sample size 4800

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Seiji HOKIMOTO
Organization Department of Cardiovascular Medicine,
Graduate School of Medical Sciences,
Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto, Kumamoto, 860-8556, JAPAN
TEL 096-373-5175
Email shokimot@kumamoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Seiji Hokimoto
Organization Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1, Honjo, Chuo-ku, Kumamoto, Kumamoto, 860-8556, JAPAN
TEL 096-373-5175
Homepage URL http://www.kumadai-junnai.com
Email shokimot@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine,
Graduate School of Medical Sciences,
Kumamoto University
Institute
Department

Funding Source
Organization grants-in-aid for scientific research from the Ministry of Education, Culture, Sports, Science and Technology,
Organization
Division
Category of Funding Organization
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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 21 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 Suspended
Date of protocol fixation
2011 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 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 evaluation of all-cause death, classified into cardiovascular death, or not

Management information
Registered date
2014 Year 07 Month 21 Day
Last modified on
2015 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016993

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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