UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016655 |
|---|---|
| Receipt number | R000018947 |
| Scientific Title | The effect of tolvaptan in heart failure patients with loop diuretic resistance. |
| Date of disclosure of the study information | 2015/02/27 |
| Last modified on | 2016/08/29 12:17:13 |
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Basic information
Public title
The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Acronym
The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Scientific Title
The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Scientific Title:Acronym
The effect of tolvaptan in heart failure patients with loop diuretic resistance.
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of tolvaptan in heart failure patients with loop diuretic resistance and the predictor of tolvaptan responder.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body weight
Key secondary outcomes
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
administration of tolvaptan
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized heart failure patients with informed consent, and whose urine production is less than 200ml over 2h after intravenous bolus of furosemide.
Key exclusion criteria
1. patients with cardiogenic shock or needs catecholamine or mechanical circulation support
2. intubation
3. obvious bleeding or active gastrointestinal ulceration
4. hemodialysis
5. hyperkalemia (6.0mEq/L)
6. hypernatremia (150mEq/L)
7. hypotension (systolic blood pressure <=85mmHg) or symptomatic hypotension
8. patients who cannot declare thirst or cannot drink water
9. hypersensitivity for Tolvaptan or Mozavaptan
10. expectant mother
11. inappropriate patients judged by the physician in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Department of cardiology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
mokayama@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Jujo |
Organization
Tokyo Women's Medical University
Division name
Department of cardiology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
juken1123@mac.com
Sponsor or person
Institute
Tokyo Women's Medical University, Department of Cardiology
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
| 2015 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 27 | 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
| 2015 | Year | 02 | Month | 27 | Day |
Last modified on
| 2016 | 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=R000018947
