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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046574
Receipt No. R000053121
Scientific Title Effect of Sacubitril/Valsartan on Natriuretic Peptide in Patients with Compensated Heart Failure
Date of disclosure of the study information 2022/01/08
Last modified on 2022/01/07

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Basic information
Public title Effect of Sacubitril/Valsartan on Natriuretic Peptide in Patients with Compensated Heart Failure
Acronym Sacubitril/Valsartan in Compensated HF
Scientific Title Effect of Sacubitril/Valsartan on Natriuretic Peptide in Patients with Compensated Heart Failure
Scientific Title:Acronym Sacubitril/Valsartan in Compensated HF
Region
Japan

Condition
Condition chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and prognostic impact of ARNI in the compensated HF.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes natriuretic peptide families
Key secondary outcomes 1) Serum Renin, aldosterone and AngiotensinII
2) medication
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), laboratory data (blood urea nitrogen, creatinine, total bilirubin, sodium, potassium, hemoglobin and C-reactive protein [CRP])
4) left ventricular ejection fraction (LVEF) on echocardiography
5) Prognosis (mortality and heart failure 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 Treatment of Sacubitril/Valsartan
Interventions/Control_2 Treatment of ACE-I
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 Compensated HF patients visiting the outpatient clinics who were administrated angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
Key exclusion criteria Patients with end-stage chronic kidney disease (eGFR<30 mL/min/1.73m2) were excluded from present study
Target sample size 80

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 Hasegawa Hospital
Address 85
Tel 043-444-0137
Email bwa41248@nifty.com

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 08 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 01 Month 19 Day
Date of IRB
2021 Year 01 Month 19 Day
Anticipated trial start date
2021 Year 01 Month 20 Day
Last follow-up date
2023 Year 12 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=R000053121

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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