UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001171 |
|---|---|
| Receipt number | R000001223 |
| Scientific Title | Registration study on acutely decompensated heart failure |
| Date of disclosure of the study information | 2008/06/02 |
| Last modified on | 2019/01/29 17:36:33 |
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Basic information
Public title
Registration study on acutely decompensated heart failure
Acronym
KICS-CHF
Scientific Title
Registration study on acutely decompensated heart failure
Scientific Title:Acronym
KICS-CHF
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the current status and prognosis of patients who are hospitalized for acutely decompensated heart failure
Basic objectives2
Others
Basic objectives -Others
Large clinical trials in the past have established pathophysiology and prognosis in patients with systolic dysfunction. However, there are considerable number of patients with preserved ventricular function. This study is undertaken to determine the current status and prognosis in overall patients who are hospitalized for decompensated heart failure.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiovascular mortality
Key secondary outcomes
hospitalization for heart failure
hospitalization for fatal ventricular arrhythmias
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
Patients with acutely decompensated heart failure who are admitted to the Keio University Hospital or affiliated hospitals
Key exclusion criteria
Patients who do not give consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Suzuki |
Organization
National Saitama Hospital
Division name
Cardiology
Zip code
Address
2-1 Suwa, Wako, Japan
TEL
048-462-1101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yoshikawa |
Organization
Secretariat of the Keio Interhopital Cardiology Study
Division name
Division of Cardiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3446
Homepage URL
tyoshi@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio Interhospital Cardiology Study Group
Institute
Department
Personal name
Funding Source
Organization
Keio Interhospital Cardiology Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2008 | Year | 06 | Month | 02 | 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
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Death or hospitalizations due to heart failure and / or arrhythmias
Management information
Registered date
| 2008 | Year | 06 | Month | 02 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001223
| 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 |
