UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029436 |
|---|---|
| Receipt number | R000033630 |
| Scientific Title | Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2020/10/11 14:31:33 |
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Basic information
Public title
Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study
Acronym
KCHF Long-term follow-up
Scientific Title
Long-term follow-up of patients enrolled in Kyoto Congestive Heart Failure (KCHF) study
Scientific Title:Acronym
KCHF Long-term follow-up
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term outcomes of all patients enrolled in KCHF study
Basic objectives2
Others
Basic objectives -Others
Retrospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause death (one year from enrollment)
Key secondary outcomes
Death from heart failure, sudden cardiac death, non-cardiac death, re-hospitalization, re-hospitalization for heart failure, arrhythmia, stroke, cardiac surgery, severe bleeding, adverse drug events
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
Patients enrolled in KCHF study (patients who
need specific intravenous heart failure treatment within 24 hours from presentation) and discharged from hospitals
Key exclusion criteria
NO consent
Target sample size
3794
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6068507
Address
54 kawahara-cho, Sakyouku, Kyoto
TEL
0757514255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6068507
Address
54 Kawahara-cho, Sakyou-ku, Kyoto
TEL
0757514255
Homepage URL
tkato75@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Ethics Committee, Kyoto University Graduate School and Faculty of Medicine
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学病院（京都府）、天理よろづ相談所病院（奈良県）、国立病院機構 京都医療センター（京都府）、三菱京都病院（京都府）、心臓病センター医療法人親友会 島原病院（京都府）、大津赤十字病院（滋賀県）、滋賀県立成人病センター（滋賀県）、彦根市立病院（滋賀県）、大阪赤十字病院（大阪府）、財団法人 田附興風会 医学研究所 北野病院（大阪府）、市立岸和田市民病院（大阪府）、関西電力病院（大阪府）、兵庫県立尼崎総合医療センター（兵庫県）、日本赤十字社和歌山医療センター（和歌山県）、静岡県立総合病院（静岡県）、神戸市立医療センター中央市民病院（兵庫県）、倉敷中央病院（岡山県）、小倉記念病院（福岡県）、京都岡本記念病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2736173
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2736173
Number of participants that the trial has enrolled
3785
Results
The cumulative 1-year incidence of the
primary outcome was statistically significantly lower in the MRA use group than in the no MRA use group. Of the components of
the primary outcome, the cumulative 1-year incidence of heart failure hospitalization was significantly lower in the MRA use group than in the no MRA use group, whereas no difference in mortality was found between the 2 groups.
Results date posted
| 2020 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 06 | Month | 21 | Day |
Baseline Characteristics
Please refer the main paper.
Participant flow
Please refer the main paper.
Adverse events
Please refer the main paper.
Outcome measures
Please refer the main paper.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 04 | Day |
Other
Other related information
This study aims to evaluate the long-term outcomes of patients enrolled KCHF registry.
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033630
| Research Plan | |
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| 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 |
