UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045300 |
|---|---|
| Receipt number | R000051742 |
| Scientific Title | Sacubitril valsartan altenating from keeping ACE-I/ARB in Heart Failure Study |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/05/24 13:55:02 |
* 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
Sacubitril valsartan altenating from keeping ACE-I/ARB in Heart Failure Study
Acronym
SAKAI-HF
Scientific Title
Sacubitril valsartan altenating from keeping ACE-I/ARB in Heart Failure Study
Scientific Title:Acronym
SAKAI-HF
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of sacubitrill-valsartan for the patients with chronic heart failure with ACE-I or ARB
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LVEF at TTE
Key secondary outcomes
other echocardiographic findings, laboratory data
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic heart failure with ACE-I or ARB
Key exclusion criteria
acute heart failure
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | masami |
| Middle name | |
| Last name | nishino |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
mnishino@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Shodai |
| Middle name | |
| Last name | Kawanami |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
Homepage URL
junnai-hisho@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
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
Osaka Rosai Hospital
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel
072-252-3561
junnai-hisho@osakah.johas.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 | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
assessment of echocardiographic findings and laboratory data at 3month and 12 month
Management information
Registered date
| 2021 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051742
