UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016566 |
|---|---|
| Receipt number | R000018926 |
| Scientific Title | Influence of cirrhotic cardiomyopathy on long-term outcomes and clinical findings including portal hemodynamics in cirrhosis |
| Date of disclosure of the study information | 2015/02/17 |
| Last modified on | 2015/02/17 20:04:23 |
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Basic information
Public title
Influence of cirrhotic cardiomyopathy on long-term outcomes and clinical findings including portal hemodynamics in cirrhosis
Acronym
Cirrhotic cardiomyopahty and portal hemodymics
Scientific Title
Influence of cirrhotic cardiomyopathy on long-term outcomes and clinical findings including portal hemodynamics in cirrhosis
Scientific Title:Acronym
Cirrhotic cardiomyopahty and portal hemodymics
Region
| Japan |
Condition
Condition
Patients with cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the relationship between cirrhotic cardiomyopathy and clinical findings including portal hemodynamics in patients with cirrhosis.
Basic objectives2
Others
Basic objectives -Others
The aim is to elucidate the influence of cirrhotic cardiomyopahty on long-term clinical outcomes in patients with cirrhosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between decompensation/liver function/portal hemodynamics and cirrhotic cardiomyopathy
Key secondary outcomes
Influence of cirrhostic cardiomyopahty on prognosis and decompensation in cirrhosis
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 cirrhosis
Key exclusion criteria
patients with use of beta-blockers
patients with hisotry of TIPS/Denver shunt
patients with arterio-portal shunt
patients with habitual drinking (> 20g/day)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Nephrology
Zip code
Address
Chuou-ku, Inohana, 1-8-1, Chiba, Japan
TEL
043-222-7171
maru-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Nephrology
Zip code
Address
Chuou-ku, Inohana, 1-8-1, Chiba, Japan
TEL
043-222-7171
Homepage URL
maru-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gasteoenterology and Nephlology, Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 02 | Month | 17 | 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
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2015 | Year | 02 | Month | 17 | Day |
Last modified on
| 2015 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018926
