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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046000
Receipt No. 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

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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
Email 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
Email kosaka.r@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School General Medical Center
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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