UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032724 |
|---|---|
| Receipt number | R000037277 |
| Scientific Title | Clinical Value of Liver Stiffness measured by Magnetic Resonance Elastography in Patients with Heart Failure. |
| Date of disclosure of the study information | 2018/05/25 |
| Last modified on | 2019/05/27 11:33:02 |
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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
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
anzai@med.hokudai.ac.jp
Public contact
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
tnagai@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
