UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Registry and follow-up study regarding medical and social conditions and outcomes of hospitalized heart failure patients: Multi-center survey in Hiroshima Heart Health Promotion Project
Title of the study (Brief title)	REAL-HF
Region	Japan

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

Objectives
Narrative objectives1	1) To elucidate the real medical and social conditions of hospitalized heart failure patients in Japan 2) To identify their real outcomes after discharge
Basic objectives2	Others
Basic objectives -Others	Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of all cause deaths and all unscheduled readmissions for 12 months after discharge
Key secondary outcomes	1) Clinical characteristics of each patient during the hospitalization, including underlying heart diseases, history of HF, physical activity (ability of independent gait), clinical test data, and treatment methods 2) Information regarding outpatient cardiac rehabilitation and home nursing-care services after discharge

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) Adult patients hospitalized with symptomatic heart failure in one of the 8 institutions participating in Hiroshima Heart Health Promotion Project 2) Symptomatic heart failure defined according to Framingham's criteria and/or low output syndrome diagnosed by primary physicians
Key exclusion criteria	none
Target sample size	1600

Research contact person
Name of lead principal investigator	Yasuki Kihara
Organization	Hiroshima University Institute of Biomedical & Health Sciences
Division name	Department of Cardiovascular Medicine
Address	Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima
TEL	082-257-5555
Email	ykihara@hiroshima-u.ac.jp

Public contact
Name of contact person	Susumu Nakayama
Organization	Hiroshima University Hospital
Division name	Heart Failure Center
Address	Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima
TEL	082-257-5711
Homepage URL
Email	snakayama@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Institute of Biomedical & Health Sciences Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 01 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 06 Day
Anticipated trial start date	2016 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Underlying heart diseases, history of heart failure, physical activity (ability of independent gait), clinical test data, and treatment methods Occurrence of all cause deaths and all unscheduled readmissions for 12 months after discharge Information regarding outpatient cardiac rehabilitation and home nursing-care services after discharge

Management information
Registered date	2017 Year 01 Month 12 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029509