UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009201 |
|---|---|
| Receipt number | R000010803 |
| Scientific Title | Efficacy and Safety of Tolvaptan in Heart Failure Patients with Renal Impairment and Volume Overload Despite the Standard Treatment with Conventional Diuretics |
| Date of disclosure of the study information | 2012/10/27 |
| Last modified on | 2015/04/30 14:30:22 |
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Basic information
Public title
Efficacy and Safety of Tolvaptan in Heart Failure Patients with Renal Impairment and Volume Overload Despite the Standard Treatment with Conventional Diuretics
Acronym
K-STAR
Scientific Title
Efficacy and Safety of Tolvaptan in Heart Failure Patients with Renal Impairment and Volume Overload Despite the Standard Treatment with Conventional Diuretics
Scientific Title:Acronym
K-STAR
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of tolvaptan in heart failure patients with renal impairment and volume overload
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urine volume
Key secondary outcomes
Body weight / Congestive symptoms / Renal function / Number of patients who were discontinued from the study due to meeting event criteria, duration from the start to the discontinuation, and discontinuation rate / Free water clearance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
Add Tolvaptan 7.5-15mg to the conventional therapy
Interventions/Control_2
Add furosemide up to 40mg to the conventional therapy
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
insufficient despite the oral diuretics or loop diuretics equivalent to furosemide 40mg or more / renal impairment whose eGFR is under 45mL/min/1.73m2 / male and female over 20 years of age ( at the time of informed consent) / inpatient / ability to informed consent
Key exclusion criteria
subjects who already administered injected HF medications (including diueretics, inotropes and vasodilators), and who already use mechanical support (mechanical ventilator such as NIPPV, IABP, PCPS, hemodialysis and hemodiafiltration) / history of allergy against tolvaptan or similar compounds / anuria / subjects who cannot feel thirsty or have difficulty to drink / hyponatremia / subjects who are pregnant or possibly pregnant /subjects who already have tolvaptan at the time of randomization / acute coronary syndrome or those who are planned percutaneous coronary intervention / malignancy / 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 | Takayuki Inomata |
Organization
Kitasato University
Division name
Cardiology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara Kanagawa
TEL
042-778-8111
inotaka@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Nakamura |
Organization
Kanagawa Aquaresis Investigators
Division name
Management office
Zip code
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara Kanagawa
TEL
042-748-7262
Homepage URL
nakamura.star@gmail.com
Sponsor or person
Institute
Kanagawa Aquaresis Investigators
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 10 | Month | 27 | 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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010803
