UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018004 |
|---|---|
| Receipt number | R000020862 |
| Scientific Title | Diuretic effect of tolvaptan in congenital heart disease Multi-center study |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/22 14:13:07 |
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Basic information
Public title
Diuretic effect of tolvaptan in congenital heart disease Multi-center study
Acronym
Diuretic effect of tolvaptan in congenital heart disease Multi-center study
Scientific Title
Diuretic effect of tolvaptan in congenital heart disease Multi-center study
Scientific Title:Acronym
Diuretic effect of tolvaptan in congenital heart disease Multi-center study
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted to evaluate effectiveness of tolvaptan as diuretics in patients with congenital heart disease and water retention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Urine volume, body weight, water intake, volume of drainage, urine osmolality, sodium concentration of urine, electrolytes, kidney function, Cre clearance, and GFR
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan administration
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who had water retention such as pleural effusion, ascitis, and cardiomegaly despite standard diuretic therapy and were started tolvaptan were included in the study.
Key exclusion criteria
Patients with renal failure and were on peritoneal dialysis, patients on mechanical circulatory support such as ventricular assist device, and extracorporeal membranous oxygenator were excluded from the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Nakanishi |
Organization
Tokyo Women's Medical University
Division name
Pediatric Cardiology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
03-3353-8111
pnamanis@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Nakanishi |
Organization
Tokyo Women's Medical University
Division name
Pediatric Cardiology
Zip code
Address
8-1 Kawada-cho Shinjuku-ku Tokyo
TEL
03-3353-8111
Homepage URL
okikim8111@hotmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
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
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
Tokyo Women's Medical University(Tokyo), Keio University (Tokyo), Okayama University (Okayama), Nagano Children's Hospital (Nagano), Shizuoka Children's Hospital (Shizuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 22 | 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
| 2014 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 12 | 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
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020862
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
