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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001171
Receipt No. 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

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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
Email

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
Email tyoshi@sc.itc.keio.ac.jp

Sponsor
Institute Keio Interhospital Cardiology Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001223

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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