UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017206
Receipt number 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 19:17:10

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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 or person

Institute

Department of Cardiovascular, MedicineHokkaido University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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