UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006212 |
|---|---|
| Receipt number | R000007328 |
| Scientific Title | A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema. |
| Date of disclosure of the study information | 2011/08/22 |
| Last modified on | 2011/08/22 19:35:04 |
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Basic information
Public title
A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Acronym
A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Scientific Title
A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Scientific Title:Acronym
A clinical study to investigate the efficacy of diuretics to the HF patients with proteinuria and edema.
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the diuretic effect of tolvaptan with existing diuretics
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight
Key secondary outcomes
edema
CTR
Ejection fraction
plasma BNP level
Base
Study type
Interventional
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 7.5mg/day (can be escalated to 15mg, if needed)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.patients who satisfy inclusion criteria as follows at the screening test
2.congestive heart failure patients who are already administered diuretics
3.patients with proteinuria and edema
4.inpatients
Key exclusion criteria
1.patients who have a history of allergens against tolvaptan or similar compounds
2.anuric patients (urinary output: <100mL/day)
3.patients who cannnot feel thirsty or have difficulty to drink
4.patients whose serum sodium level is over 147mEq/L
5.pregnant or possibly pregnant woman
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazo Kaizu |
Organization
Social Insurance Yokohama Central Hospital
Division name
Department of Nephrology and Blood purification
Zip code
Address
268, Yamashita-cho, Naka-ku, Yokohama, Kanagawa, Japan
TEL
045-641-1921
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazo Kaizu |
Organization
Social Insurance Yokohama Central Hospital
Division name
Department of Nephrology and Blood purification
Zip code
Address
268, Yamashita-cho, Naka-ku, Yokohama, Kanagawa, Japan
TEL
045-641-1921
Homepage URL
Sponsor or person
Institute
Social Insurance Yokohama Central Hospital
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
| 2011 | Year | 08 | 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
| 2011 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2011 | Year | 08 | Month | 22 | Day |
Last modified on
| 2011 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007328
