UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042876 |
|---|---|
| Receipt number | 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 12:51:50 |
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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
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
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
