UMIN-CTR Clinical Trial

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	3402
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 09 Month 30 Day

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