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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009924
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Showa University Northern Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011629

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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