UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study of prognostic factors for acute heart failure
Acronym	Kokura CHF Registry 2015
Scientific Title	A retrospective observational study of prognostic factors for acute heart failure
Scientific Title:Acronym	Kokura CHF Registry 2015
Region	Japan

Condition
Condition	congestive heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the current status of treatment and clinical outcomes and to survey the prognostic factors in patients with congestive heart failure.
Basic objectives2	Others
Basic objectives -Others	retrospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	all-cause death, and rehospitalization for heart failure
Key secondary outcomes	cardiac death, bleeding event, ischemic event, arrhythmia event, renal failure event

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients hospitalized for worsening congestive heart failure
Key exclusion criteria	Age < 18
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Isotani Middle name Last name Akihiro
Organization	Kokura memorial hospital
Division name	cardiology
Zip code	8028555
Address	Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL	093-511-2000
Email	isotani1978@gmail.com

Public contact
Name of contact person	1st name Kenji Middle name Last name Kanenawa
Organization	Kokura memorial hospital
Division name	cardiology
Zip code	8028555
Address	Asano3-2-1, Kokurakita-ku, Kitakyusyu-shi
TEL	093-511-2000
Homepage URL
Email	kanesannsann@yahoo.co.jp

Sponsor
Institute	Kokura memorial hospital
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	linical research center,Kokura Memorial Hospital
Address	3-2-1 Asano, Kokura kita-ku,Kitakyushu-city,
Tel	0935112000
Email	crc@kokurakinen.or.jp

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	2020 Year 08 Month 31 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	600
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	No longer recruiting
Date of protocol fixation	2018 Year 12 Month 06 Day
Date of IRB	2019 Year 02 Month 12 Day
Anticipated trial start date	2019 Year 02 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective cohort study

Management information
Registered date	2020 Year 08 Month 23 Day
Last modified on	2020 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047401