UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Value of Liver Stiffness measured by Magnetic Resonance Elastography in Patients with Heart Failure.
Acronym	Clinical Value of Liver Stiffness measured by Magnetic Resonance Elastography in Patients with Heart Failure.
Scientific Title	Clinical Value of Liver Stiffness measured by Magnetic Resonance Elastography in Patients with Heart Failure.
Scientific Title:Acronym	Clinical Value of Liver Stiffness measured by Magnetic Resonance Elastography in Patients with Heart Failure.
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study sought to clarify the correlation of CVP and liver stiffness measured by MR elastography, and determine the relationship between liver stiffness and the prognosis of heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. the correlation of CVP and liver stiffness measured by MR elastography in heart failure patients 2. the relationship between liver stiffness measured by MR elastography and the prognosis of heart failure (all cause death, re-hospitalization for heart failure).
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	1. heart failure group Heart failure patients admitted to Hokkaido University Hospital. 2. non heart failure group A person who has no apparent history of heart failure at the time of participation in research at Hokkaido University Hospital. * The definition of "heart failure" in this study shall be in accordance with the guidelines published by the European Society of Cardiology in 2016.
Key exclusion criteria	1. Patients who have organic liver disease such as chronic liver injury, liver cirrhosis, hepatocellular carcinoma 2. Patients who are inappropriate for MRI imaging 3. Patients who are judged to be inappropriate as the research subject by the research staff
Target sample size	330

Research contact person
Last name of lead principal investigator	1st name Toshihisa Middle name Last name Anzai
Organization	Hokkaido University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	0608648
Address	Kita15 Nishi7,Kita-ku,Sapporo,Hokkaido
TEL	011-706-6973
Email	anzai@med.hokudai.ac.jp

Public contact
1st name of contact person	1st name Toshiyuki Middle name Last name Nagai
Organization	Hokkaido University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	0608648
Address	Kita15 Nishi7,Kita-ku,Sapporo,Hokkaido
TEL	011-706-6973
Homepage URL
Email	tnagai@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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	Hokkaido University Hospital Clinical Research and Medical Inovation Center
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648 Japan
Tel	011-706-7061
Email	crjimu@huhp.hokudai.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	2018 Year 05 Month 25 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 12 Day
Date of IRB	2018 Year 03 Month 12 Day
Anticipated trial start date	2018 Year 04 Month 26 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2018 Year 05 Month 25 Day
Last modified on	2019 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037277