UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective single-center observational study of heart failure
Acronym	Retrospective single-center observational study of heart failure
Scientific Title	Retrospective single-center observational study of heart failure
Scientific Title:Acronym	Retrospective single-center observational study of heart failure
Region	Japan

Condition
Condition	Heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationships between patient characteristics and clinical outcomes in heart failure.
Basic objectives2	Others
Basic objectives -Others	To evaluate the relationships among patient characteristics in heart failure.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	All cause mortality
Key secondary outcomes	Hospitalization for heart failure urgent admission for heart failure composite of all cause death or hospitalization for heart failure composite of all cause death, hospitalization for heart failure, or urgent admission for heart failure

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	Hospitalized or admitted heart failure patient in Okayama University Hospital
Key exclusion criteria	Refusing study participation
Target sample size	5600

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Ito
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Depertment of cardiovascular medicine
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Email	itomd@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Iwasaki
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Depertment of cardiovascular medicine
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Homepage URL
Email	p8w24uzd@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	None
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Commitee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	086-235-6938
Email	mae6605@adm.okayama-u.ac.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	2022 Year 09 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	Open public recruiting
Date of protocol fixation	2022 Year 07 Month 20 Day
Date of IRB	2022 Year 08 Month 26 Day
Anticipated trial start date	2022 Year 08 Month 26 Day
Last follow-up date	2030 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The study duration survey period is from the IRB approval day to December 31th, 2022.

Management information
Registered date	2022 Year 08 Month 30 Day
Last modified on	2022 Year 08 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055590