UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Registration study on acutely decompensated heart failure
Title of the study (Brief title)	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	Masahiro Suzuki
Organization	National Saitama Hospital
Division name	Cardiology
Address	2-1 Suwa, Wako, Japan
TEL	048-462-1101
Email

Public contact
Name of contact person	Tsutomu Yoshikawa
Organization	Secretariat of the Keio Interhopital Cardiology Study
Division name	Division of Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001223