UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060698 |
|---|---|
| Receipt number | R000069390 |
| Scientific Title | A prospective observational study to clarify risk factors for progression of frailty in elderly patients with heart failure |
| Date of disclosure of the study information | 2026/02/18 |
| Last modified on | 2026/02/17 16:43:16 |
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Basic information
Public title
A prospective observational study to clarify risk factors for progression of frailty in elderly patients with heart failure
Acronym
Frail-eldHF Study
Scientific Title
A prospective observational study to clarify risk factors for progression of frailty in elderly patients with heart failure
Scientific Title:Acronym
Frail-eldHF Study
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the incidence and risk factors of frailty progression in elderly patients with heart failure
Basic objectives2
Others
Basic objectives -Others
A prospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frailty progression
Key secondary outcomes
Prognosis, heart failiure re-hospitalization, cardiovascular events and non-cardiovascular events in two years, Changes in physical status and other indicators for frailty, QOL
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 admitted to participating facilities for acute heart failure between December 2024 and March 2027
(2) Patients aged 65 or over
(3) Able to walk
(4) Participating in cardiac rehabilitation during hospitalization
Key exclusion criteria
(1) Patients scheduled for coronary revascularisation (PCI), cardiac surgery, pacemaker therapy, or catheter ablation after discharge
(2) Unable to walk
(3) Patinets on hemodialysis
(4) Unable to follow
(5) Patients deemed unsuitable for participation in this study by the principal investigator
Target sample size
410
Research contact person
Name of lead principal investigator
| 1st name | Moritake |
| Middle name | |
| Last name | Iguchi |
Organization
Kyoto medical center
Division name
Department of cardiac rehabilitation
Zip code
612-8555
Address
1-1, Fukakusamukouhatachou, Fushimiku, Kyoto, Japan
TEL
075-641-9161
moritake.igu@gmail.com
Public contact
Name of contact person
| 1st name | Moritake |
| Middle name | |
| Last name | Iguchi |
Organization
Kyoto medical center
Division name
Department of cardiac rehabilitation
Zip code
612-8555
Address
1-1, Fukakusamukouhatachou, Fushimiku, Kyoto, Japan
TEL
075-641-9161
Homepage URL
moritake.igu@gmail.com
Sponsor or person
Institute
Kyoto Medical Center, Division of translational research
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Clinical Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The central ethics committee of the National Hospital Organization headquarters
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.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
| 2026 | Year | 02 | Month | 18 | 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
| 2025 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Management information
Registered date
| 2026 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069390
