UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009924 |
|---|---|
| Receipt number | R000011629 |
| Scientific Title | A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2015/12/25 22:49:42 |
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Basic information
Public title
A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography
Acronym
A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography
Scientific Title
A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography
Scientific Title:Acronym
A study to evaluate the dose-response effect of tolvaptan 7.5mg or 15mg in HF patients who undergo cartdiac angiography
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the frequency of contrast-induced nephropathy within 48 hours after the administration of radiocontrast agents and the safety of tolvaptan 7.5mg daily with tolvaptan 15mg daily
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of contrast-induced nephropathy within 48 hours after the administration of radiocontrast agents
Key secondary outcomes
(1)Renal injury at 48h after the procedure (Percent changes of serum creatinine /CysC/BNP/urinary albumin) (2) Major post-procedure in-hospital adverse clinical events, including cardiogenic shock, clinically significant arrhythmia, CIN requiring renal replacement therapy (hemofiltration or homodiafiltration), pulmonary edema, and death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan 15mg
Interventions/Control_2
Tolvaptan 7.5mg
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Heart failure patients who undergo cardiac angiography
(2)ability of oral administration
(3)male or female subjects over 20 years of age at the time of informed consent
(4)ability to provide written informed consent
(5)eGFR<60
Key exclusion criteria
(1)history of allergy against this drug or similar compounds
(2)anuria (urine volume <100ml/day)
(3)subjects who cannot feel thirsty or
have difficulty to drink
(4)subjects whose serum sodium level is over 147mEq/L
(5)subjects who are pregnant or possibly pregnant
(6)subjects who already have tolvaptan at the entry
(7)acute coronary syndrome
(8)patients who are judged to be inappropriate to this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kennosuke Yamashita |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of cardiology and Cardiovascular Surgery
Zip code
Address
35-1 Chigaskichuo, Tsuzuki-ku, Yokohama Kanagawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kennosuke Yamashita |
Organization
Showa University Northern Hospital
Division name
Division of cardiology and Cardiovascular Surgery
Zip code
Address
35-1 Chigaskichuo, Tsuzuki-ku, Yokohama Kanagawa
TEL
045-949-7000
Homepage URL
Sponsor or person
Institute
Showa University Northern 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
| 2013 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011629
| Research Plan | |
|---|---|
| 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 |
