UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059996 |
|---|---|
| Receipt number | R000068572 |
| Scientific Title | Sarcopenia and its natural trajectories with prospective multicenter analysis in older patients with heart failure from the northern Japanese region |
| Date of disclosure of the study information | 2025/12/15 |
| Last modified on | 2025/12/05 15:04:33 |
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Basic information
Public title
Sarcopenia and its natural trajectories with prospective multicenter analysis in older patients with heart failure from the northern Japanese region
Acronym
SNOWMAN-HF registry
Scientific Title
Sarcopenia and its natural trajectories with prospective multicenter analysis in older patients with heart failure from the northern Japanese region
Scientific Title:Acronym
SNOWMAN-HF registry
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this multi-center prospective observational study is to quantitatively assess the dynamic changes (trajectories) of sarcopenia (SP) in elderly heart failure (HF) patients, utilizing an HF-specific estimated Appendicular Skeletal Muscle Mass (ASMI) assessment method developed by the investigators. Furthermore, the study aims to verify the association between the temporal change in SP and long-term prognosis (including all-cause mortality and HF rehospitalization) following discharge.
Basic objectives2
Others
Basic objectives -Others
Exploratory cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
1. A composite endpoint including cardiovascular death, non-cardiovascular death, hospitalization due to heart failure, stroke, bleeding events, pneumonia, and falls/fractures
2. Presence and severity of sarcopenia and changes in its components including muscle mass, muscle strength, and physical function
3. Physical, social, and cognitive frailty and changes in their constituent elements
4. Changes in activities of daily living (ADL) capability as measured by the Barthel Index from baseline (at discharge) to 1-year follow-up, categorized as either progression or improvement
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
2. Admitted for decompensated heart failure
3. Able to ambulate independently at discharge
4. Heart failure diagnosed according to the Japanese Circulation Society/Japanese Heart Failure Society Guidelines
5. Provision of written informed consent for study participation
Key exclusion criteria
1. low serum BNP (<100pg/ml) / NT-pro BNP (<300pg/ml) level on admission
2. Planned valvular surgical procedures at discharge
3. Pulmonary arterial hypertension
4. Chronic thromboembolic pulmonary hypertension
5. Chronic dialysis or planned initiation of dialysis at discharge
6. Planned or undergone heart transplantation or left ventricular assist device
7. Acute myocarditis
8. Peripheral arterial disease (Rutherford classification I-IV)
9. Central or peripheral neurological disorders affecting muscle function
10. Severe arthritis or orthopedic conditions limiting physical assessment
11. Active malignancy or systemic inflammatory conditions
12. Unable to complete SWE measurements
13. Life expectancy < 1 year due to non-cardiac conditions
14. Participation in other interventional clinical trials
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Katano |
Organization
Sapporo Medical University Hospital / Sapporo Medical University
Division name
Division of Rehabilitation / Department of Rehabilitation School of Medicine
Zip code
0608543
Address
291, South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
s.katano@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Katano |
Organization
ivision of Rehabilitation / Department of Rehabilitation, School of Medicine
Division name
Division of Rehabilitation / Department of Rehabilitation, School of Medicine
Zip code
0608543
Address
291, South 1 West 16, Chuo-ku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
s.katano@sapmed.ac.jp
Sponsor or person
Institute
Department of Rehabilitation, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Sapporo Medical University
Address
291, South 1 West 16, Chuo-ku, Sapporo, Japan
Tel
011-611-2111
ji-rskk@ml.sapmed.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
| 2025 | Year | 12 | Month | 15 | 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
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design: Multi-center Prospective Cohort Study
Institutions: Eight medical institutions in Hokkaido.
Inclusion criteria: Patients aged 65 years or older who were hospitalized for decompensated heart failure (HF) and capable of independent ambulation (4m walk) upon discharge
Observation items: HF-specific estimated Appendicular Skeletal Muscle Mass (ASMI), physical function (e.g., gait speed, grip strength), nutritional status (e.g., MNA-SF score), cardiac function (e.g., Left Ventricular Ejection Fraction), and basic blood tests
Evaluation timing: Baseline (at discharge), 1 year post-discharge (for physical function and sarcopenia [SP] dynamics), and 2 years post-discharge (for prognostic outcomes)
Primary endpoint: All-cause mortality within 2 years after discharge
This study's academic originality lies in utilizing a standardized, multi-center assessment method (estimated ASMI) to capture the temporal changes (dynamic assessment) of sarcopenia-which was previously impossible with conventional single-point assessments (static assessment)-across a large cohort. The research further aims to establish a high-precision prognostic prediction model based on these dynamic change patterns. By achieving this paradigm shift from static diagnosis to dynamic prediction, the ultimate goal is to establish the foundation for personalized medicine in heart failure care, thereby contributing to the extension of the healthy lifespan of elderly patients in Japan's super-aging society.
Management information
Registered date
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068572
