UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046000 |
|---|---|
| Receipt number | R000052508 |
| Scientific Title | Evaluation for the effectiveness of Sacubitril-valsartan for acute type B aortic dissection. |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2021/11/07 01:22:25 |
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Basic information
Public title
Evaluation for the effectiveness of Sacubitril-valsartan for acute type B aortic dissection.
Acronym
Evaluation for the effectiveness of Sacubitril-valsartan for acute type B aortic dissection.
Scientific Title
Evaluation for the effectiveness of Sacubitril-valsartan for acute type B aortic dissection.
Scientific Title:Acronym
Evaluation for the effectiveness of Sacubitril-valsartan for acute type B aortic dissection.
Region
| Japan |
Condition
Condition
Acute type B aortic dissection
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy for renal function and respiratory function of Sacubitril-valsartan in conservative treatment of acute type B aortic dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the change of renal function during the conservative treatment of aortic dissection for a week after the onset.
Blood tests and urine samples will be evaluated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sacubitril-valsartan will be administered for a week after the onset additionally to the basic anti-hypertensive medicine.
Interventions/Control_2
Control group. Patients will be treated with anti-hypertensive medicine without sacubitril-valsartan.
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 acute type B aortic dissection who are treated with conservative antihypertensive treatment
Key exclusion criteria
Complicated cases necessitate emergent or urgent surgery, patients with dialysis, patients who cannot take medicine orally, patients who cannot accept the informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Watanabe |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of General Surgery
Zip code
7008505
Address
2-6-1, Nakasange, Kita
TEL
0862252111
kosaka.r@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotone |
| Middle name | |
| Last name | Tsujimoto |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of General Surgery
Zip code
7008505
Address
2-6-1, Nakasange, Kita
TEL
0862252111
Homepage URL
kosaka.r@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School General Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Sakakibara Heart Institute of Okayama
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School General Medical Center
Address
2-6-1, Nakasange, Kita, Okayama, 7008505
Tel
0862252111
kosaka.r@med.kawasaki-m.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
川崎医科大学総合医療センター(岡山県)、心臓病センター榊原病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2021 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052508
| 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 |
