UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046583
Receipt No. R000053142
Scientific Title Effect of Sacubitril/Valsartan in Patients with Acute Exacerbation of Chronic Heart Failure
Date of disclosure of the study information 2022/01/10
Last modified on 2022/01/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Enrolling by invitation
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 01 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.