UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057756 |
|---|---|
| Receipt number | R000066008 |
| Scientific Title | Prospective cohort study on the assessment of skeletal muscle viscoelastic properties using ultrasound shear wave elastography and its prognostic significance in elderly patients with heart failure |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/18 16:17:36 |
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Basic information
Public title
Prospective cohort study on the assessment of skeletal muscle viscoelastic properties using ultrasound shear wave elastography and its prognostic significance in elderly patients with heart failure
Acronym
VISMARC-HF
Scientific Title
Prospective cohort study on the assessment of skeletal muscle viscoelastic properties using ultrasound shear wave elastography and its prognostic significance in elderly patients with heart failure
Scientific Title:Acronym
VISMARC-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sarcopenia frequently coexists with heart failure and is associated with poor prognosis, but conventional assessment methods inadequately capture qualitative muscle changes. The purpose of this study is to evaluate the utility of skeletal muscle viscoelastic property assessment using ultrasound shear wave elastography in elderly heart failure patients and to elucidate its prognostic significance.
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
500
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
Division 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
JSPS KAKENHI Grant number JP 25K10715
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
s.katano@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 | 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 | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 09 | 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: Single-center prospective cohort study
Inclusion Criteria: Patients aged 65 years or older admitted for decompensated heart failure who can ambulate independently at discharge.
Observation Items: In addition to patient information, routine blood tests, and physical examinations, skeletal muscle viscoelastic properties will be assessed using ultrasound shear wave elastography (SWE) of the gastrocnemius muscle, biceps brachii, and quadriceps muscle at rest and passive extension. Sarcopenia indicators will include handgrip strength, gait speed, five-times sit-to-stand test (FTSS), Short Physical Performance Battery (SPPB), and appendicular skeletal muscle mass measurement by dual-energy X-ray absorptiometry (DEXA). Bioelectrical impedance analysis (BIA) will measure body water content and phase angle. In a subgroup (approximately 20%), magnetic resonance imaging (MRI) will evaluate muscle mass, fat infiltration, and fibrosis, while magnetic resonance spectroscopy (MRS) will assess muscle energy metabolism for detailed validation of SWE measurements. All participants will be followed for clinical outcomes for up to 2 years.
Management information
Registered date
| 2025 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066008
