UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058192 |
|---|---|
| Receipt number | R000066525 |
| Scientific Title | Impact of Combined Frailty and Sarcopenia on HAD and Short-Term Prognosis in Older Patients with Chronic Heart Failure: A Japan-Korea Multicenter Observational Study |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/16 16:46:59 |
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Basic information
Public title
A Study on Frailty, Sarcopenia, and In-Hospital Activities of Daily Living Decline in Older Patients with Chronic Heart Failure in Japan and Korea
Acronym
J-K CHF Frailty-Sarcopenia Study
Scientific Title
Impact of Combined Frailty and Sarcopenia on HAD and Short-Term Prognosis in Older Patients with Chronic Heart Failure: A Japan-Korea Multicenter Observational Study
Scientific Title:Acronym
J-K CHF Frailty-Sarcopenia Study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the prevalence and overlap of frailty and sarcopenia in older patients with chronic heart failure in Japan and Korea, and to examine their impact on hospital-associated disability (HAD) as well as short-term prognosis, including readmission and mortality within 30, 90, and 180 days after discharge. Through an international, multicenter retrospective observational study, we seek to clarify the dose-response relationship of overlapping geriatric syndromes and contribute evidence to improve risk assessment and discharge planning in the management of elderly heart failure patients in Asia.
Basic objectives2
Others
Basic objectives -Others
To retrospectively examine the impact of overlapping frailty and sarcopenia on hospital-associated disability (HAD), readmission, and mortality in older patients with chronic heart failure. This study also aims to provide foundational data to improve risk stratification and discharge support systems for elderly heart failure patients in Asia, through international comparison between Japan and Korea.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Prevalence of frailty in older patients with chronic heart failure in Japan and Korea
2. Prevalence of sarcopenia in the same population
3. Prevalence of coexisting frailty and sarcopenia
4. Incidence of hospital-associated disability(HAD) at the time of hospital discharge
Key secondary outcomes
1. Readmission rates within 30, 90, and 180 days after hospital discharge
2. Mortality rates within 30, 90, and 180 days after hospital discharge
3. Impact of coexisting frailty and sarcopenia on these readmission and mortality 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 65 years or older who are admitted to a participating hospital in Japan or Korea due to chronic heart failure
2. Patients whose clinical condition has stabilized after acute treatment and who are deemed eligible for assessment by both the attending physician and physical therapist
3. Patients who are judged to be capable of undergoing frailty and sarcopenia assessments safely during hospitalization
4. Patients (or legal representatives) who provide written informed consent after receiving sufficient explanation of the study
Key exclusion criteria
1. Patients for whom clinical assessment is deemed inappropriate due to acute myocardial infarction or other serious acute illnesses
2. Patients with severe dementia or impaired communication making it difficult to conduct evaluation or obtain informed consent
3. Patients with physical conditions that prevent the safe implementation of muscle function or basic mobility assessments
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | HYUNJAE |
| Middle name | |
| Last name | WOO |
Organization
Wakayama Professional University of Rehabilitation
Division name
Department of Physical Therapy
Zip code
6408222
Address
1cho, 3chome, Minatohonmachi, Wakayama City, Wakayama Prefecture, Japan
TEL
0734354888
hyunjae0610@gmail.com
Public contact
Name of contact person
| 1st name | HYUNJAE |
| Middle name | |
| Last name | WOO |
Organization
Wakayama Professional University of Rehabilitation
Division name
Department of Physical Therapy
Zip code
6408222
Address
1cho, 3chome, Minatohonmachi, Wakayama City, Wakayama Prefecture, Japan
TEL
0734354888
Homepage URL
hyunjae0610@gmail.com
Sponsor or person
Institute
Wakayama Professional University of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki University Hospital (Japan), Bucheon Sejong Hospital (Korea)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Professional University of Rehabilitation
Address
1cho, 3chome, Minatohonmachi, Wakayama City, Wakayama Prefecture, Japan
Tel
0734354888
hyunjae0610@gmail.com
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
| 2025 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The IRB approval has been obtained at the principal institution, but the application is still under review at the collaborating site. Patient enrollment is planned to begin in or after August 2025.
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066525
