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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017206
Receipt No. R000019958
Scientific Title Assessment of Acute Kidney Injury by using DW-MRI in Patients with congestive heart failure
Date of disclosure of the study information 2015/04/21
Last modified on 2015/11/25

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Basic information
Public title Assessment of Acute Kidney Injury by using DW-MRI in Patients with congestive heart failure
Acronym AKI asseessment by DW-MRI in CHF patients
Scientific Title Assessment of Acute Kidney Injury by using DW-MRI in Patients with congestive heart failure
Scientific Title:Acronym AKI asseessment by DW-MRI in CHF patients
Region
Japan

Condition
Condition Chronic Heart Failure
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantitative Assessment of renal congestion by using DW-MRI in patients with congestive haert failure
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To Assess the accuracy of data derived from DW-MRI compared with CVP value by catheraization
Key secondary outcomes

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Quantitative analysis of renal congestion by usisng DW-MRI
Interventions/Control_2 catheterization
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
80 years-old >
Gender Male and Female
Key inclusion criteria Enrolled patients who were admitted to department of cardiovascular medicine in Hokkaido University Hospital
<CHF Group>
1.NYHA is more than and 2
2.BNP is more than and 100pg/ml
<Healthy Control Group>
1.LVEF derived from 2D echocardiogaraphy is more than and 50%
2.BNP is less than 100pg/ml
3.e-GFR is more than and 60mL/min/1.73 m2
Key exclusion criteria 1. Paients who can not get the informed consents

2. Those who can not perform MRI due to some reason including implantation of pacemecker and ICD etc.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tsutsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo
TEL 011-706-6971
Email htsutsui@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Sakakibara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL 011-706-6973
Homepage URL
Email mike.s@ninus.ocn.ne.jp

Sponsor
Institute Department of Cardiovascular, MedicineHokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Cardiovascular, MedicineHokkaido University Graduate School of Medicine
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 北海道大学病院 (Hokkaido University Hospital)

Other administrative information
Date of disclosure of the study information
2015 Year 04 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 Completed
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2015 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019958

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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