UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029416 |
|---|---|
| Receipt number | R000033610 |
| Scientific Title | Clinical outcome and independent predictor in acute heart failure treated with tolvaptan: retrospective analysis |
| Date of disclosure of the study information | 2017/10/04 |
| Last modified on | 2022/06/19 12:15:14 |
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Basic information
Public title
Clinical outcome and independent predictor in acute heart failure treated with tolvaptan: retrospective analysis
Acronym
Clinical outcome and independent predictor in acute heart failure treated with tolvaptan
Scientific Title
Clinical outcome and independent predictor in acute heart failure treated with tolvaptan: retrospective analysis
Scientific Title:Acronym
Clinical outcome and independent predictor in acute heart failure treated with tolvaptan
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
assess the long-term outcome for the patients of acute heart failure using tolvaptan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular death
Key secondary outcomes
i) all cause death
ii) readmission due to worsening of heart failure
iii) independent predictor for death and readmission due to worsening of heart failure
iv) changes in serum creatinine level between at admission and discharge
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
acute decompensated heart failure treated with tolvaptan between January 2012 and September 2015
Key exclusion criteria
the patients with malignant tumor
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of medicine II
Zip code
Address
10-15 Fumizono-cho Moriguchi city, Osaka
TEL
06-6992-1001
kmatsumura1980@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Matsumura |
Organization
Kansai Medical University Medical Center
Division name
Department of medicine II
Zip code
Address
10-15 Fumizono-cho Moriguchi city, Osaka
TEL
06-6992-1001
Homepage URL
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai Medical University
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
| 2017 | Year | 10 | Month | 04 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 31 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2017 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033610
