UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046355 |
|---|---|
| Receipt number | R000052894 |
| Scientific Title | Juntendo Hospitalized Heart Failure Registry:J-HHF registry |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2021/12/12 00:32:32 |
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Basic information
Public title
Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Acronym
Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Scientific Title
Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Scientific Title:Acronym
Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to patient background and treatment, information on lifestyle and physical function of heart failure patients will be collected and analyzed in a sufficient number of samples at multiple sites, and the results will be shared with team members.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital death from any cause, mortality within 30 days, 90 days, and 1 year after discharge from hospital from any cause, readmission rates within 30 days, 90 days, and 1 year after discharge from hospital for heart failure, stroke and hemorrhagic events within 1 year
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Age 20 years or older at the time of obtaining consent
(2) The main disease at the time of discharge is heart failure.
(3) Patients who have received sufficient explanation about participation in this study prior to discharge, and who have obtained the free written consent of the research subject or the written consent of a substitute.
Key exclusion criteria
(1) Those who have not obtained written consent from the research subject himself/herself or a substitute.
(2) Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Matsue |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
y-matsue@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Dotare |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
t-dotare@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
| 2021 | Year | 12 | Month | 17 | 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
| 2020 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional observational study without randomization
Patients admitted to the Department of Cardiology at Juntendo University Hospital for the primary reason of heart failure between the date of approval and March 31, 2023, and who meet the selection criteria
Management information
Registered date
| 2021 | Year | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052894
