UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015238 |
|---|---|
| Receipt number | R000017241 |
| Scientific Title | Kyoto Congestive Heart Failure Study |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2020/04/02 14:36:03 |
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Basic information
Public title
Kyoto Congestive Heart Failure Study
Acronym
KCHF
Scientific Title
Kyoto Congestive Heart Failure Study
Scientific Title:Acronym
KCHF
Region
| Japan |
Condition
Condition
congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate current status of treatment and long-term outcomes of congestive heart failure patients in Japan
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause death
Composite endpoint of death and hospitalization for heart failure
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
Patients hospitalized for worsening congestive heart failure
Key exclusion criteria
Patients with :
Acute coronary syndrome
BT on admission over 37.5 degrees C or concomitant of infection
end-stage of renal failure (hemodialysis or serum
Cre over 3.0mg/dL)
Age < 20
Concomitant of severe conditions (terminal of
cancer, end-stage of liver cirrhosis, etc)
difficulty of follow-up
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Hospital
Division name
Cardiovascular medecine
Zip code
Address
54, kawahara-cho, shogoin, sakyo-ku, kyoto
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Erika Yamamoto |
Organization
Kyoto University Hospital
Division name
Cardiovascular medecine
Zip code
Address
54, kawahara-cho, shogoin, sakyo-ku, kyoto
TEL
075-751-4255
Homepage URL
erkymmt@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2014 | Year | 10 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective cohort study aims to evaluate clinical outcomes of Japanese patients with congestive heart failure.
Management information
Registered date
| 2014 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
