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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
