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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024023
Receipt No. R000027541
Scientific Title Validation of aortic valve stenosis in hemodialysis patients
Date of disclosure of the study information 2016/09/12
Last modified on 2019/03/20

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Basic information
Public title Validation of aortic valve stenosis in hemodialysis patients
Acronym Aortic valve stenosis in hemodialysis patients
Scientific Title Validation of aortic valve stenosis in hemodialysis patients
Scientific Title:Acronym Aortic valve stenosis in hemodialysis patients
Region
Japan

Condition
Condition Patients who undergo maintenance hemodialysis
Classification by specialty
Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validation of the prevalence of aortic valve stenosis
Validation of disease stages and progression of aortic valve stenosis
Basic objectives2 Others
Basic objectives -Others Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease stage of aortic valve stenosis
Follow-up period is 5 years.
Key secondary outcomes Hospitalization due to cardiovascular and cerebrovascular disease
Cardiovascular death
All-cause death

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
99 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing maintenance hemodialysis
Key exclusion criteria Patients who do not give informed consent
Patients who are lost to follow up
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Yoriko
Middle name
Last name Horiguchi
Organization Sagami Junkanki Clinic
Division name Department of Internal Medicine
Zip code 252-0312
Address 4-21-15, Sounan, Minami-ku, Sagamihara City, Kanagawa
TEL 0427462211
Email dzq04361@nifty.com

Public contact
Name of contact person
1st name Yoriko
Middle name
Last name Horiguchi
Organization Sagami Junkanki Clinic
Division name Department of Internal Medicine
Zip code 252-0312
Address 4-21-15, Sounan, Minami-ku, Sagamihara City, Kanagawa
TEL 0427462211
Homepage URL
Email dzq04361@nifty.com

Sponsor
Institute Sagami Junkanki Clinic
Institute
Department

Funding Source
Organization No source of funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sagami Junkanki Clinic
Address 4-21-15, Sounan, Minami-ku, Sagamihara City, Kanagawa, Japan
Tel 0427462211
Email sa.jc118@gaea.ocn.ne.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
2016 Year 09 Month 12 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
2016 Year 02 Month 02 Day
Date of IRB
2016 Year 02 Month 02 Day
Anticipated trial start date
2016 Year 02 Month 02 Day
Last follow-up date
2021 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027541

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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