UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011721 |
|---|---|
| Receipt number | R000013705 |
| Scientific Title | Randomized controlled trial on the safety and EffectiVeness Of toLvaptan for flUid retenTion after OpeN heart surgery |
| Date of disclosure of the study information | 2013/09/12 |
| Last modified on | 2013/09/12 10:24:56 |
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Basic information
Public title
Randomized controlled trial on the safety and EffectiVeness Of toLvaptan for flUid retenTion after OpeN heart surgery
Acronym
REVOLUTION study
Scientific Title
Randomized controlled trial on the safety and EffectiVeness Of toLvaptan for flUid retenTion after OpeN heart surgery
Scientific Title:Acronym
REVOLUTION study
Region
| Japan |
Condition
Condition
opoen heart surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety andeffectiveness of tolvaptan for fluid retention after open heart surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The days before returning to preoperative weight after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tolvaptan
Interventions/Control_2
standard therapy
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
heart failure
open heart surgery
Key exclusion criteria
hypersensitivity
anuresis
hypernatremia
pregnant woman
malignant tumor
serious liver samage and renal failure
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi university
Division name
Surgery and clinical science
Zip code
Address
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL
+81-836-22-2261
kimikazu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Kudo |
Organization
Yamaguchi university
Division name
Surgery and clinical science
Zip code
Address
1-1-1, Minamikogushi, Ube, Yamaguchi, Japan
TEL
+81-836-22-2261
Homepage URL
t-kudoh@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2013 | Year | 09 | Month | 12 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 12 | Day |
Last modified on
| 2013 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013705
