UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019545
Receipt number R000022599
Scientific Title Evaluation of Liver and Kidney Congestion Evaluated by Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure
Date of disclosure of the study information 2015/10/29
Last modified on 2015/10/28 18:28:22

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Basic information

Public title

Evaluation of Liver and Kidney Congestion Evaluated by Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure

Acronym

Evaluation of Liver and Kidney Congestion by elastography in Patients with Heart Failure

Scientific Title

Evaluation of Liver and Kidney Congestion Evaluated by Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure

Scientific Title:Acronym

Evaluation of Liver and Kidney Congestion by elastography in Patients with Heart Failure

Region

Japan


Condition

Condition

Congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of VTQ for the assessment of cardiac hemodynamics obtained from right heart catheterization in HF patients without organic liver or kidney diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To investigate relation of organ stiffness between Normal valliant and patients with heart

Key secondary outcomes



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

Patients with HF more than New York Heart Association 2
History of hospitalization due to worsening HF
Left ventricular ejection fraction is less than 50% by the echocardiography
Plasma brain natriuretic peptideis more than 100 pg/ml

Key exclusion criteria

Region of interest is more than 8.0cm from the body surface
estimated glomerular filtration rate (eGFR) is less than 15 ml/min/1.73m2

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Tsutsui

Organization

Hokkaido University guraduate school of medicine

Division name

Department of Cardiovascular medicine

Zip code


Address

Hokkaido Sapporoshi Kitaku kita15jyounishi7tyoume

TEL

011-706-6973

Email

mike.s@ninus.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Yoshitani

Organization

Hokkaido University guraduate school of medicine

Division name

Department of Cardiovascular medicine

Zip code


Address

Hokkaido Sapporoshi Kitaku kita15jyounishi7tyoume

TEL

011-706-6973

Homepage URL


Email

mike.s@ninus.ocn.ne.jp


Sponsor or person

Institute

Hokkaido University guraduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

none

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


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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 29 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 14 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

recruiting


Management information

Registered date

2015 Year 10 Month 28 Day

Last modified on

2015 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022599


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name