UMIN-CTR Clinical Trial

Basic information
Public title	The incidence and characterization of patients with heart failure who need national Long-Term Care Insurance
Acronym	Long-Term Care Insurance in heart failure
Scientific Title	The incidence and characterization of patients with heart failure who need national Long-Term Care Insurance
Scientific Title:Acronym	Long-Term Care Insurance in heart failure
Region	Japan

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

Objectives
Narrative objectives1	To identify the incidence and clinical indicators of long term care insurance in heart failure
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of long term care insurance in heart failure
Key secondary outcomes	The clinical indicators of long term care insurance in 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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	left ventricular ejection fraction under 50%
Key exclusion criteria	Patients who were already on LTCI at the time of echocardiography
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Email	sfujiki@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Homepage URL
Email	sfujiki@med.niigata-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Biology and Medicine Niigata University Graduate School of Medical and Dental Science
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	General hospital conducting echocardiography in Niigata city
Name of secondary funder(s)	The Medical Association of Niigata City

IRB Contact (For public release)
Organization	The ethical committees of Niigata University
Address	1-757 Asahimachidori, Chuo-ku, Niigata
Tel	025-227-2625
Email	ethics@adm.niigata-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	新潟大学医歯学総合病院

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 05 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	2016 Year 06 Month 16 Day
Date of IRB	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2022 Year 02 Month 01 Day
Date of closure to data entry	2022 Year 02 Month 01 Day
Date trial data considered complete	2022 Year 02 Month 01 Day
Date analysis concluded	2022 Year 02 Month 01 Day

Other
Other related information	We check the medical record information and extract data at the time of registration and investigate the occurrence of long-term care insurance using the official documents for doctor's opinion.

Management information
Registered date	2021 Year 02 Month 05 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049367