UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044773 |
|---|---|
| Receipt number | R000051139 |
| Scientific Title | Effect of sacubitril-valsartan on cardiac function in hemodialysis patients |
| Date of disclosure of the study information | 2021/07/06 |
| Last modified on | 2021/07/06 16:46:42 |
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Basic information
Public title
Effect of sacubitril-valsartan on cardiac function in hemodialysis patients
Acronym
Sacubitril-valsartan in hemodialysis patients
Scientific Title
Effect of sacubitril-valsartan on cardiac function in hemodialysis patients
Scientific Title:Acronym
Sacubitril-valsartan in hemodialysis patients
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effect of sacubitril-valsartan on cardiac function in hemodialysis patients with heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in left ventricular ejection fraction and N-terminal proBNP level(pre, 4, 8 and 12 weeks).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50 mg of sacubitril-valsartan twice daily at least 12 weeks
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
LVEF<50% or N-terminal proBNP >5000 ng/L
Key exclusion criteria
sys. BP <120 mmHg
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Daimon |
Organization
Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Division name
Department of Nephrology
Zip code
921 8802
Address
Oshino 1-400, Nonoichi, Japan
TEL
+81762940077
dai-clinic@m2.spacelan.ne.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Daimon |
Organization
Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Division name
Department of Nephrology
Zip code
921 8802
Address
Oshino 1-400, Nonoichi, Japan
TEL
+81762940077
Homepage URL
dai-clinic@m2.spacelan.ne.jp
Sponsor or person
Institute
Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Institute
Department
Personal name
Funding Source
Organization
No funding was received for this study
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
Daimon Clinic for Internal Medicine, Nephrology and Dialysis
Address
Oshino 1-400, Nonoichi, Japan
Tel
+81762940077
dai-clinic@m2.spacelan.ne.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 | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 25 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051139
