UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052872 |
|---|---|
| Receipt number | R000060337 |
| 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 2 |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2024/11/22 09:08:35 |
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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 2
Acronym
REAL-HF 2
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 2
Scientific Title:Acronym
REAL-HF 2
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 7 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
1400
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Nakano |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Cardiovascular Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5555
nakanoy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuho |
| Middle name | |
| Last name | Yamaguchi |
Organization
Hiroshima University Hospital
Division name
Heart Failure Center
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima
TEL
082-257-5711
Homepage URL
mizuho46@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Graduate School of Biomedical and Health Sciences
Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Self Procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital Heart Failure Center
Address
Kasumi 1-2-3 Minami-ku, Hiroshima-shi, Hiroshima
Tel
082-257-5711
mizuho46@hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060337
