UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023594 |
|---|---|
| Receipt number | R000024988 |
| Scientific Title | The association between urine response to tolvaptan and hospitalization period in patients with acute heart failure |
| Date of disclosure of the study information | 2016/08/11 |
| Last modified on | 2016/08/11 22:47:58 |
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Basic information
Public title
The association between urine response to tolvaptan and hospitalization period in patients with acute heart failure
Acronym
Tolvaptan response and hospitalization period
Scientific Title
The association between urine response to tolvaptan and hospitalization period in patients with acute heart failure
Scientific Title:Acronym
Tolvaptan response and hospitalization period
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to clarify the characteristics of responder to tolvaptan among acute heart failure patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical profile of responder to tolvaptan
Key secondary outcomes
Patients stay period in CCU and hospital
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
This study included consecutive patients who were hospitalized due to acute heart failure and were treated with tolvaptan.
Key exclusion criteria
Patients who were already receiving daily tolvaptan before admission and patients with maintenance dialysis were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohito Kogure |
Organization
Tokyo women medical university
Division name
Department of Cardiology
Zip code
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
tomohito.kogure.j@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Jujo |
Organization
Nishiarai Heart Center Hospital
Division name
Department of Cardiology
Zip code
Address
1-12-8 Nishiaraihoncho, Adachi-ku, Tokyo, Japan
TEL
03-5838-0730
Homepage URL
juken1123@mac.com
Sponsor or person
Institute
Department of cardiology, Nishiarai Heart Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Nishiarai Heart Center Hospital
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
西新井ハートセンター病院/Nishiarai Heart Center Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 11 | 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
| 2011 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Durations in intensive care unit and total hospitalization were significantly shorter in Responders (median: 6.0 vs. 13.0 days, p=0.024; 15.0 vs. 22.0 days, p=0.047, respectively).
Management information
Registered date
| 2016 | Year | 08 | Month | 11 | Day |
Last modified on
| 2016 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024988
