UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Sacubitril/Valsartan in Patients with Acute Exacerbation of Chronic Heart Failure
Acronym	Sacubitril/Valsartan and Acute Heart Failure
Scientific Title	Effect of Sacubitril/Valsartan in Patients with Acute Exacerbation of Chronic Heart Failure
Scientific Title:Acronym	Sacubitril/Valsartan and Acute Heart Failure
Region	Japan

Condition
Condition	Acute Exacerbation of Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect and the prognostic impact of Sacubitril/Valsartan un patients with acute exacerbation of heart failure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes to the natriuretic peptide families (BNP, NT-proBNP and ANP)
Key secondary outcomes	1) serum renin, aldosterone and AngiotensinII 2) medications 3) age, gender, presence of de novo or recurrent HF, etiology of HF, past medical history (risk factors for atherosclerosis [diabetes mellitus, hypertension, and dyslipidemia], and chronic kidney disease), vital signs (systolic blood pressure [SBP] and heart rate), presence of orthopnea, arterial blood gas data, laboratory data (blood urea nitrogen, creatinine, total bilirubin, sodium, potassium, hemoglobin, BNP, C-reactive protein [CRP] 4)left ventricular ejection fraction (LVEF) on echocardiography 5)long-term prognosis (all cause death and HF event within 1 year)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Change of therapy from ACE-I/ARB to ARNI (100mg/day), followed by 14 days of treatment
Interventions/Control_2	Continue treatment with ACE-I/ARB for 14 days
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with acute exacerbation of heart failure who require intensive care. (All patients were already administrated ACE-I or ARB) 2) Patients from whom written informed consent.
Key exclusion criteria	1) Patients heart failure due to ST elevation myocardial infarction 2) Patients with end-stage chronic kidney disease (eGFR<30 mL/min/1.73m2) were excluded from present study. 3) Patients who satisfied the matters that requires attention in appended paper.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Shirakabe
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Intensive Care Unit
Zip code	2701694
Address	1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL	0476991111
Email	s6042@nms.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Shirakabe
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Intensive Care Unit
Zip code	2701694
Address	1715 Kamagari, Inzai, Chiba 270-1694, Japan
TEL	0476991111
Homepage URL
Email	s6042@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	None
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	Nippon Medical School Chiba Hokusoh Hospital
Address	1715 Kamagari, Inzai, Chiba 270-1694, Japan
Tel	0476991111
Email	araraki@nms.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	2022 Year 01 Month 10 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 07 Month 01 Day
Date of IRB	2021 Year 07 Month 01 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2025 Year 07 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	2022 Year 01 Month 07 Day
Last modified on	2022 Year 07 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053142