UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016566
Receipt No. 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

* 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 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
Email 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
Email maru-cib@umin.ac.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.