UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038637 |
|---|---|
| Receipt number | R000041197 |
| Scientific Title | Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island |
| Date of disclosure of the study information | 2019/11/20 |
| Last modified on | 2021/05/21 09:36:49 |
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Basic information
Public title
Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Acronym
Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Scientific Title
Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Scientific Title:Acronym
Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict the current status of the incidence of hospitalized heart failure in Japan using population-based HF registry
Basic objectives2
Others
Basic objectives -Others
To predict the future status of the incidence of hospitalized heart failure in Japan using population-based HF registry
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate the numbers of hospitalized heart failure in Japan
Key secondary outcomes
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
heart failure hospitalization
Key exclusion criteria
residents living out side of Awaji island
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Fujimoto |
Organization
Awaji medical center
Division name
cardiology
Zip code
656-0021
Address
Shioya1-1-137, Sumoto, Hyogo, Japan
TEL
0799221200
watarutaru_328@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Fujimoto |
Organization
Awaji medical center
Division name
Caldiology
Zip code
656-0021
Address
Shioya1-1-137, Sumoto, Hyogo, Japan
TEL
0799221200
Homepage URL
watarutaru_328@yahoo.co.jp
Sponsor or person
Institute
Awaji medical center
Institute
Department
Personal name
Funding Source
Organization
Awaji medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Awaji medical center
Address
Shioya1-1-137, Sumoto, Hyogo, Japan
Tel
0799221200
watarutaru_328@yahoo.co.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
兵庫県立淡路医療センター（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
file:///C:/Users/Fujimoto%20Wataru/Desktop/HF%20registry%20paper/KUNIUMI%20acute%20(first%20paper).p
Publication of results
Published
Result
URL related to results and publications
file:///C:/Users/Fujimoto%20Wataru/Desktop/HF%20registry%20paper/KUNIUMI%20acute%20(first%20paper).p
Number of participants that the trial has enrolled
1155
Results
Using the general population of Japan as of 2015 as a standard, age- and sex-adjusted
incidence rates for AHFS were 133.8 per 100,000 person-years for male and 120.0 for female. In 2015, there were an estimated
159,702 new-onset patients with AHFS.
Results date posted
| 2021 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 03 | Month | 05 | Day |
Baseline Characteristics
Patients hospitalized with acute heart failure syndrome in Awaji Island
Participant flow
Patients were included from 8 hospitals.
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All of patients with hospitalized acute heart failure in participated institution from January 1 in 2015 to December 31 in 2017 were included.
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041197
| 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 |
