UMIN-CTR Clinical Trial

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
Email	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
Email	erkymmt@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017241