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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026756
Receipt No. R000030719
Scientific Title Prognosis of dialysis patients with aortic valve stenosis: multicenter prospective cohort study
Date of disclosure of the study information 2017/04/01
Last modified on 2019/04/01

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Basic information
Public title Prognosis of dialysis patients with aortic valve stenosis: multicenter prospective cohort study
Acronym Prognosis of dialysis patients with aortic valve stenosis
Scientific Title Prognosis of dialysis patients with aortic valve stenosis: multicenter prospective cohort study
Scientific Title:Acronym Prognosis of dialysis patients with aortic valve stenosis
Region
Japan

Condition
Condition End-stage kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine factors associatted with mortality in dialysis patients with aortic valve stenosis
Basic objectives2 Others
Basic objectives -Others To examine factors associatted with incidence of cardiovascular event in dialysis patients with aortic valve stenosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause mortality
Key secondary outcomes Cardiovascular related mortality
Incidence of cardiovascular event

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 All dialysis patients who were undergone ultracardiosonography
Key exclusion criteria Patients with post valve operation
Patients who refused participation in the study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Daijo
Middle name
Last name Inaguma
Organization Fujita Health University School of Medicine
Division name Department of Nephrology
Zip code 470-1192
Address Dengakugakubo 1-98, Kutsukake, Toyoake city, Aichi, Japan
TEL 0562-93-9245
Email daijo@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Daijo
Middle name
Last name Inaguma
Organization Fujita Health University School of Medicine
Division name Department of Nephrology
Zip code 470-1192
Address Dengakugakubo 1-98, Kutsukake, Toyoake city, Aichi, Japan
TEL 0562-93-9245
Homepage URL
Email daijo@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine
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 Center for reserch promotion and support
Address Dengakugakubo 1-98, Kutsukake, Toyoake city, Aichi
Tel 0562-93-2865
Email irb-sys@fujita-hu.ac.jp

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
2017 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 23 Day
Date of IRB
2017 Year 04 Month 13 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Answers to the prognostic survey were obtained from medical records of the institutions or by sending letters to facilities where patients had been transferred for maintenance dialysis. These letters included a questionnaire regarding the category of CV events

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030719

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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