UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052508