UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018009 |
|---|---|
| Receipt number | R000020872 |
| Scientific Title | Non randomized trial to compare efficacy of tolvaptan and trichlormethiazide in adult congenital heart disease |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/22 15:02:34 |
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Basic information
Public title
Non randomized trial to compare efficacy of tolvaptan and trichlormethiazide in adult congenital heart disease
Acronym
Non randomized trial to compare efficacy of tolvaptan and trichlormethiazide
Scientific Title
Non randomized trial to compare efficacy of tolvaptan and trichlormethiazide in adult congenital heart disease
Scientific Title:Acronym
Non randomized trial to compare efficacy of tolvaptan and trichlormethiazide
Region
| Japan |
Condition
Condition
adult congenital heart disease
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of tolvaptan and trichlormethiazide in adult congenital heart disaese
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality in 6 month, rate and frequency of re-admission, urine osmolity and sodium concentration, serum electrolytes
Key secondary outcomes
body weight, sign of congestion, side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of tolvaptan
Interventions/Control_2
administration of trichlormethiazide
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.admitted to the hospital for congestive heart failure
2.water retention regardless of standard diuretic therapy
3.Sign of congestive heart failure
4. obtained written informed consent
Key exclusion criteria
1.Ventricular assist device
2.Complicated with low cardiac output syndrome, HCM, under inotrope infusion, and hepatic coma.
3. Aneuria or uncontrolled diabetes.
Target sample size
12
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
pnakanis@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikiko Shimizu |
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
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 | 13 | 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=R000020872
