UMIN-CTR Clinical Trial

Basic information
Public title	Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Acronym	Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Scientific Title	Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Scientific Title:Acronym	Estimated numbers of heart failure hospitalization in Japan using background of patients of heart failure hospitalization in Awaji island
Region	Japan

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

Objectives
Narrative objectives1	To predict the current status of the incidence of hospitalized heart failure in Japan using population-based HF registry
Basic objectives2	Others
Basic objectives -Others	To predict the future status of the incidence of hospitalized heart failure in Japan using population-based HF registry
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To estimate the numbers of hospitalized heart failure in Japan
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	heart failure hospitalization
Key exclusion criteria	residents living out side of Awaji island
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Wataru Middle name Last name Fujimoto
Organization	Awaji medical center
Division name	cardiology
Zip code	656-0021
Address	Shioya1-1-137, Sumoto, Hyogo, Japan
TEL	0799221200
Email	watarutaru_328@yahoo.co.jp

Public contact
Name of contact person	1st name Wataru Middle name Last name Fujimoto
Organization	Awaji medical center
Division name	Caldiology
Zip code	656-0021
Address	Shioya1-1-137, Sumoto, Hyogo, Japan
TEL	0799221200
Homepage URL
Email	watarutaru_328@yahoo.co.jp

Sponsor
Institute	Awaji medical center
Institute
Department

Funding Source
Organization	Awaji medical center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	JPN

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

IRB Contact (For public release)
Organization	Awaji medical center
Address	Shioya1-1-137, Sumoto, Hyogo, Japan
Tel	0799221200
Email	watarutaru_328@yahoo.co.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	兵庫県立淡路医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 20 Day

Related information
URL releasing protocol	file:///C:/Users/Fujimoto%20Wataru/Desktop/HF%20registry%20paper/KUNIUMI%20acute%20(first%20paper).p
Publication of results	Published

Result
URL related to results and publications	file:///C:/Users/Fujimoto%20Wataru/Desktop/HF%20registry%20paper/KUNIUMI%20acute%20(first%20paper).p
Number of participants that the trial has enrolled	1155
Results	Using the general population of Japan as of 2015 as a standard, age- and sex-adjusted incidence rates for AHFS were 133.8 per 100,000 person-years for male and 120.0 for female. In 2015, there were an estimated 159,702 new-onset patients with AHFS.
Results date posted	2021 Year 05 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 03 Month 05 Day
Baseline Characteristics	Patients hospitalized with acute heart failure syndrome in Awaji Island
Participant flow	Patients were included from 8 hospitals.
Adverse events	None
Outcome measures	None
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB	2018 Year 11 Month 02 Day
Anticipated trial start date	2018 Year 11 Month 15 Day
Last follow-up date	2019 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	All of patients with hospitalized acute heart failure in participated institution from January 1 in 2015 to December 31 in 2017 were included.

Management information
Registered date	2019 Year 11 Month 19 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041197