UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036417 |
|---|---|
| Receipt number | R000041491 |
| Scientific Title | Renal protective effect of tolvaptan in patients with new-onset acute heart failure |
| Date of disclosure of the study information | 2019/05/15 |
| Last modified on | 2022/06/19 12:14:17 |
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Basic information
Public title
Renal protective effect of Samsca in patients with new-onset acute heart failure
Acronym
Renal protective effect of Samsca
Scientific Title
Renal protective effect of tolvaptan in patients with new-onset acute heart failure
Scientific Title:Acronym
Renal protective effect of tolvaptan
Region
| Japan |
Condition
Condition
Acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate short-term protective effect of tolvaptan for worsening renal function in patients with new-onset acute heart failure, and to observe long-term cardiovascular outcome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of worsening renal function during hospitalization between tolvaptan group and furosemide group
Key secondary outcomes
Composite outcome (all cause mortality, heart failure rehospitalization and renal impairment)
All cause mortality
Heart failure rehospitalization
Renal impairment
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hospitalized with new-onset acute heart failure
NYHA 3 or 4
Less than 40mg dose of furosemide prescribed at admission
Key exclusion criteria
Concomitant acute coronary syndrome
History of tolvaptan treatment before hospitalization
Hemodialysis patient
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
570-0056
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL
+81-6-6991-1001
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Bandou |
Organization
Kansai Medical University Medical Center
Division name
Department of Cardiology
Zip code
570-8507
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
TEL
+81-6-6992-1001
Homepage URL
bandoshi@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Medical Center
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
Kansai Medical university Medical Center
Address
10-15, Fumizono-cho, Moriguchi, Osaka Japan
Tel
+81-6-6992-1001
bandoshi@takii.kmu.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
| 2019 | Year | 05 | Month | 15 | 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
122
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
Main results already published
Date of protocol fixation
| 2019 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 05 | Day |
Other
Other related information
Retrospective enrollment and prospective observational study
Management information
Registered date
| 2019 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041491
