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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042876
Receipt No. R000048938
Scientific Title Clinical study on the interrelationship between liver, heart, and lung in portal hypertension
Date of disclosure of the study information 2021/01/04
Last modified on 2020/12/30

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Basic information
Public title Clinical study on the interrelationship between liver, heart, and lung in portal hypertension
Acronym The interrelationship between liver, heart, and lung in portal hypertension
Scientific Title Clinical study on the interrelationship between liver, heart, and lung in portal hypertension
Scientific Title:Acronym The interrelationship between liver, heart, and lung in portal hypertension
Region
Japan

Condition
Condition Portal hypertension
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the frequency of cardiac function abnormalities and pulmonary hypertension in patients with portal hypertension, changes in cardiac function and pulmonary hypertension after treatment of complications of portal hypertension, and to clarify the clinical significance of cirrhotic cardiomyopathy and portopulmonary hypertension.
Basic objectives2 Others
Basic objectives -Others Epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of cirrhotic cardiomyopathy and portopulmonary hypertension in patients with portal Hypertension and at 3 months and 1 year
Key secondary outcomes a. Examine the relationship between liver reserve values (blood chemistry, Child-Pugh score, MELD score, and liver elasticity) and cardiac and portopulmonary hypertension factors.
b. Examine the relationship between portal hemodynamic severity (hepatic venous pressure gradient, Doppler flow factors in portal vein and portosystemic shunt) and cardiac function factors and pulmonary hypertension factors.
c. To examine changes in cardiac function and pulmonary hypertension factors after treatment of complications associated with portal hypertension.
d. Examine the relationship of prognosis to cardiac function and pulmonary hypertension factors.
e. Examine differences in endothelin, cytokines, and BMP9

by angiographic site and changes after treatment.

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) Patients scheduled for treatment of complications associated with portal hypertension (splenomegaly, portal hypertension, esophagogastric varices, refractory ascites) or patients suspected of having cirrhotic cardiomyopathy or portopulmonary hypertension due to respiratory distress, etc.
2) Age 20 years or older
3) Patients who have received sufficient explanation about the study after receiving sufficient explanation about their medical conditions and treatment methods, and who have obtained written consent of their own free will with sufficient understanding.
Key exclusion criteria (1) Patients whom the principal investigator or sub-investigator judges to be inappropriate as subjects.
(2) Patients for whom outpatient follow-up at our hospital is difficult.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kato
Middle name
Last name Naoya
Organization Chiba University Graduate School of Medicine
Division name Deartment of Gastroenterology
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL 0432227171
Email takakon@chiba-u.jp

Public contact
Name of contact person
1st name Kondo
Middle name
Last name Takayuki
Organization Chiba University Hospital
Division name Department of Gastroenterology
Zip code 260-8677
Address 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan
TEL 0432227171
Homepage URL
Email takakon@chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization N/A
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 Chiba Univesity Graduate School of Medicine, IRB
Address 1-8-1, Inohana, Chuo-ku, Chiba, Japan
Tel 0432227171
Email inohana-rinri@chiba-u.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
2021 Year 01 Month 04 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 Enrolling by invitation
Date of protocol fixation
2020 Year 10 Month 12 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2020 Year 12 Month 30 Day
Last modified on
2020 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048938

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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