UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048788 |
|---|---|
| Receipt number | R000055590 |
| Scientific Title | Retrospective single-center observational study of heart failure |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/08/30 12:02:29 |
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Basic information
Public title
Retrospective single-center observational study of heart failure
Acronym
Retrospective single-center observational study of heart failure
Scientific Title
Retrospective single-center observational study of heart failure
Scientific Title:Acronym
Retrospective single-center observational study of heart failure
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationships between patient characteristics and clinical outcomes in heart failure.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationships among patient characteristics in heart failure.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause mortality
Key secondary outcomes
Hospitalization for heart failure
urgent admission for heart failure
composite of all cause death or hospitalization for heart failure
composite of all cause death, hospitalization for heart failure, or urgent admission for heart failure
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized or admitted heart failure patient in Okayama University Hospital
Key exclusion criteria
Refusing study participation
Target sample size
5600
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Depertment of cardiovascular medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Iwasaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Depertment of cardiovascular medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
Homepage URL
p8w24uzd@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Commitee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2022 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study duration survey period is from the IRB approval day to December 31th, 2022.
Management information
Registered date
| 2022 | Year | 08 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
