UMIN-CTR Clinical Trial

Basic information
Public title	Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Acronym	Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Scientific Title	Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Scientific Title:Acronym	Juntendo Hospitalized Heart Failure Registry:J-HHF registry
Region	Japan

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

Objectives
Narrative objectives1	In addition to patient background and treatment, information on lifestyle and physical function of heart failure patients will be collected and analyzed in a sufficient number of samples at multiple sites, and the results will be shared with team members.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital death from any cause, mortality within 30 days, 90 days, and 1 year after discharge from hospital from any cause, readmission rates within 30 days, 90 days, and 1 year after discharge from hospital for heart failure, stroke and hemorrhagic events within 1 year
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	(1) Age 20 years or older at the time of obtaining consent (2) The main disease at the time of discharge is heart failure. (3) Patients who have received sufficient explanation about participation in this study prior to discharge, and who have obtained the free written consent of the research subject or the written consent of a substitute.
Key exclusion criteria	(1) Those who have not obtained written consent from the research subject himself/herself or a substitute. (2) Others who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Yuya Middle name Last name Matsue
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	y-matsue@juntendo.ac.jp

Public contact
Name of contact person	1st name Taishi Middle name Last name Dotare
Organization	Juntendo University Graduate School of Medicine
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	t-dotare@juntendo.ac.jp

Sponsor
Institute	Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	None

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

IRB Contact (For public release)
Organization	Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	hongo-rinri@juntendo.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	2021 Year 12 Month 17 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	2020 Year 12 Month 14 Day
Date of IRB	2021 Year 01 Month 29 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Non-interventional observational study without randomization Patients admitted to the Department of Cardiology at Juntendo University Hospital for the primary reason of heart failure between the date of approval and March 31, 2023, and who meet the selection criteria

Management information
Registered date	2021 Year 12 Month 12 Day
Last modified on	2021 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052894