UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014312 |
|---|---|
| Receipt number | R000016339 |
| Scientific Title | Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease. |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/08/29 17:21:39 |
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Basic information
Public title
Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.
Acronym
TOLVAPTAN study
Scientific Title
Examination of efficacy of tolvaptan for chronic congective heart failure complicated with chronic kidney disease.
Scientific Title:Acronym
TOLVAPTAN study
Region
| Japan |
Condition
Condition
Chronic congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of tolvaptan for chronic heart failure with chronic kidney disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement effect of the heart failure
Key secondary outcomes
BNP, renin activity, aldosteron, catecholamine, CRE, cystatin C, urine L-FABP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Tolvaptan
Interventions/Control_2
Furosemide
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
Patients of congestive heart failure hospitalized with the chronic kidney disease that presented body fluid retention even if taken more than furosemide 20mg/day.
Key exclusion criteria
Patients who had acute myocardial infarction within 30 days .
Patients of active myocarditis or the amyloid cardiomyopathy.
Patients who are supported by circulation device.
Patients who had decrease in circulation blood volume.
Patients with hypertrophic cardiomyopathy (except the expansion aspect).
Patients with severe valvular disease.
Patients with hepatogenic comatose.
Patients with insufficient treatment on diabetes mellitus.
Patients whose blood pressure is less than 90mmHg.
Patients that following electrolytes abnormality is accepted.
Serum Na>147mEq/L, serum K>5.5mEq/L
Patients who cannot take oral formulation.
Patients with a pregnant woman, a nursing girl, pregnant possibility or the intention to become pregnant.
Patients that are recognized as inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6523
minatos@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Minatoguchi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6523
Homepage URL
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Department of Cardiology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Gifu University Graduate School of Medicine
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
| 2014 | Year | 07 | Month | 01 | 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
| 2012 | Year | 06 | Month | 20 | 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
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016339
