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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025651
Receipt No. R000029509
Scientific Title 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
Date of disclosure of the study information 2017/01/12
Last modified on 2018/12/13

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Basic information
Public title 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
Acronym REAL-HF
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuki Kihara
Organization Hiroshima University Institute of Biomedical & Health Sciences
Division name Department of Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Susumu Nakayama
Organization Hiroshima University Hospital
Division name Heart Failure Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 12 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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