UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046455 |
|---|---|
| Receipt number | R000053007 |
| Scientific Title | Combination of sacubitril valsartan and vericiguat in patients with heart failure and reduced ejection fraction |
| Date of disclosure of the study information | 2021/12/23 |
| Last modified on | 2021/12/23 17:55:51 |
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Basic information
Public title
Combination of sacubitril valsartan and vericiguat in patients with heart failure and reduced ejection fraction
Acronym
Salvage trial
Scientific Title
Combination of sacubitril valsartan and vericiguat in patients with heart failure and reduced ejection fraction
Scientific Title:Acronym
Combination of sacubitril valsartan and vericiguat in patients with heart failure : SALVAGE trial
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment for patients with chronic heart failure has a lot of evidence but is still a poor prognosis. The purpose of this study is to compare the changes in NT-proBNP between the sacubitril / valsartan alone group and the sacubitril / valsartan + vericiguat combination group in HFrEF patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NT-proBNP at 6 month and i year later
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
Randomly assigned to sacubitril / valsartan alone group and the sacubitril / valsartan + vericiguat combination group
Interventions/Control_2
Randomly assigned to sacubitril / valsartan alone group and the sacubitril / valsartan + vericiguat combination group
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
Heart failure with reduced ejection fraction
Key exclusion criteria
Chronic renal disease (crea>2.0)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Wakeyama |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Division of Crdiology
Zip code
745-8522
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL
0834-28-4411
wakeyama@icloud.com
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Wakeyama |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Division of Cardiology
Zip code
745-8522
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL
0834-28-4411
Homepage URL
wakeyama@icloud.com
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokuyama Central Hospital Ethics Committee
Address
1-1, Kodachou, Shunan, Yamaguchi, Japan
Tel
0834-28-4411
irb-cr@tokuyama.jcjo.go.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
| 2021 | Year | 12 | Month | 23 | 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 | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 12 | Month | 23 | Day |
Last modified on
| 2021 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053007
