UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046583 |
|---|---|
| Receipt number | 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 | 2022/07/09 11:51:27 |
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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
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
s6042@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
