UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044690 |
|---|---|
| Receipt number | R000051047 |
| Scientific Title | Portal hemodynamic effects of Sacubitril valsartan in liver disease patients with hart failure: a prospective cohort study |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2021/11/15 22:41:36 |
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Basic information
Public title
Portal hemodynamic effects of Sacubitril valsartan in liver disease patients with hart failure: a prospective cohort study
Acronym
Portal hemodynamic effects of Sacubitril valsartan
Scientific Title
Portal hemodynamic effects of Sacubitril valsartan in liver disease patients with hart failure: a prospective cohort study
Scientific Title:Acronym
Portal hemodynamic effects of Sacubitril valsartan
Region
| Japan |
Condition
Condition
liver disease patients with hart failure
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the portal hemodynamic effect of Sacubitril valsartan in liver disease patients with hart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in portal venous area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Start Sacubitril valsartan at 50 mg twice daily and double the dose within 56days, as tolerated by the patient.
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
Chronic liver disuse with heart failure
Key exclusion criteria
1) Patients with history of hypersensitivity to any of the other ingredients of Sacubitril valsartan
2)Under administration of angiotensin converting enzyme inhibitor
3)History of angioedema
4)History of severe liver disease(Child-Pugh C)
5)Pregnancy or possibility of pregnancy
6)Patients judged as inadequate at the discretion of physicians
7)Patients not approving the study consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology, Internal Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
+81-42-778-7750
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology, Internal Medicine
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
+81-42-778-7750
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University 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
Kitasato University School of Medicine Institutional Review Board
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-u.ac.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 | 06 | Month | 28 | 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
| 2021 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051047
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
