UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023114 |
|---|---|
| Receipt number | R000026641 |
| Scientific Title | Prognostic Role of Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2018/12/17 12:02:19 |
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Basic information
Public title
Prognostic Role of Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure
Acronym
Prognostic Role of Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure
Scientific Title
Prognostic Role of Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure
Scientific Title:Acronym
Prognostic Role of Virtual Touch Quantification Method of Tissue Elasticity Imaging in Patients with Heart Failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study sought to determine the prognostic significance of liver stiffness assessed by Virtual Touch Quantification(VTQ) method in patients with reduced ejection fraction (HFrEF).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was heart failure hospitalization.
Key secondary outcomes
The primary outcome was death from any cause or documented sustained VT or ventricular assist device (VAD) or heart failure hospitalization.
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
over 20 years old
NHYA class2-4
BNP>100 pg/mL
LVEF<50%
Key exclusion criteria
liver illness
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru sakakibara |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita15 Nishi7,Kita-ku,Sapporo,Hokkaido
TEL
011-706-7935
mike-s@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru sakakibara |
Organization
Hokkaido University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita15 Nishi7,Kita-ku,Sapporo,Hokkaido
TEL
011-706-7935
Homepage URL
mike-s@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
Address
Tel
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
| 2016 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 06 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026641
