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

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 - VISMARC-HF

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000057756

Enrollment

500

Registered

2025-07-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
All-cause mortality	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactSatoshi Katano

Division of Rehabilitation / Department of Rehabilitation, School of Medicine Division of Rehabilitation / Department of Rehabilitation, School of Medicine

s.katano@sapmed.ac.jp011-611-2111

Outcome results