Skip to content

Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

Multimodal Approach to Sarcopenia and Its Prognostic Impact in Older Patients Hospitalized for Acute Heart Failure (MUSICA Study).

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07530029
Acronym
MUSICA
Enrollment
110
Registered
2026-04-14
Start date
2026-05-05
Completion date
2027-11-01
Last updated
2026-06-23

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

Conditions

Acute Heart Failure (AHF), Heart Failure, Sarcopenia

Keywords

Acute Heart Failure (AHF), Sarcopenia, Point-of-care ultrasound (PoCUS), Biomarkers, Heart Failure with Preserved Ejection Fraction

Brief summary

Acute heart failure (AHF) is the leading cause of hospitalization in people over 65, with the group with preserved ejection fraction (HFpEF) being the most closely related to aging. Among its comorbidities, sarcopenia stands out, and its assessment requires measurement of muscle mass. Muscle ultrasound is an accessible and economical alternative, although its prognostic value is still uncertain. The presence of common pathophysiological mechanisms between HF-PEF and sarcopenia leads to the study of biomarkers to improve their characterization. Multimodal characterization of sarcopenia, integrating muscle mass and strength with skeletal and cardiac muscle biomarkers, will improve prognostic stratification at discharge in elderly patients with HFpEF hospitalized for ACS. We seek to evaluate the prognostic value of muscle mass estimated by ultrasound, in combination with strength measurements and circulating biomarkers related to sarcopenia, as this could improve the prediction of clinical events after hospitalization for AHF in elderly patients with HFpEF. In addition, ultrasound estimation of muscle mass will be analyzed against BIA, the relationship between skeletal and cardiac muscle will be characterized, and the usefulness of the multimodal approach to sarcopenia will be evaluated. This study is observational, prospective, and single-center. It will include 110 patients hospitalized for AHF aged ≥80 years. Events will be monitored for 6 months after discharge. Variables include clinical data, ultrasound data (lung, VExUS, and muscle mass), congestion markers (BNP, CA125), biomarkers (GDF-15, sST2, BDNF, and myostatin/follistatin), bioimpedance, and dynamometry. Data will be analyzed using regression models and survival analysis to identify prognostic factors. This study has the potential to improve the clinical management of patients with acute heart failure by providing key information on its interaction with sarcopenia. The results could help identify more effective strategies to reduce rehospitalization and mortality in these patients, improving their prognosis and quality of life.

Interventions

None listed

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with HF-pEF (LVEF ≥50%), hospitalized for AHF, with signs of fluid overload and requiring intravenous diuretic treatment. The diagnosis of HF will be made in accordance with ESC-2021 guidelines based on the presence of typical signs and symptoms, elevated natriuretic peptides (BNP \>100 pg/mL or NTproBNP \>300 pg/mL), and evidence of underlying structural heart disease by transthoracic echocardiography (performed during admission or within a period of 24 months prior to admission). * Age ≥ 80 years. * NYHA functional class II-IV.

Exclusion criteria

* End-of-life care. * Inability to comply with study procedures. * Already included patients on readmission.

Design outcomes

Primary

MeasureTime frameDescription
Composite outcome of all-cause mortality and worsening heart failureFrom enrollment to the end of the 6-month period after hospital discharge.We will measure a composite outcome of all-cause mortality and worsening heart failure in a 6-month period. Worsening heart failure will be defined as rehospitalization for any cause, urgent emergency room visits for heart failure, or visits to the Heart Failure Unit with administration of iv diuretics.

Secondary

MeasureTime frameDescription
All cause mortalityFrom enrollment to the end of the 6-month period after hospital discharge.All-cause mortality will be determined in a 6-month period by using information from the electronic health records.
Hospitalization for any causeFrom enrollment to the end of the 6-month period after hospital discharge.Hospitalizations for any cause in a 6-month period will be recorded by review of the electronic health records.
Emergency room (ER) visits for heart failureFrom enrollment to the end of the 6-month period after hospital discharge.ER visits for heart failure will be recorded in a 6-month period by reviewing health care electronic records.
Need for intravenous diuretics in a Heart Failure Unit visitFrom enrollment to the end of the 6-month period after hospital discharge.All episodes of Heart Failure Unit visits requiring intravenous diuretic administration will be recorded by reviewing electronic health records in a 6-month period.

Countries

Spain

Contacts

CONTACTAlberto Pérez-Nieva, MD
apnieva@salud.madrid.org+34 913 36 80 00
CONTACTCristina Fernández Soler
cfsoler@salud.madrid.org+34 913 36 80 00
PRINCIPAL_INVESTIGATORAlberto Pérez Nieva

Hospital Universitario Ramón y Cajal

PRINCIPAL_INVESTIGATORBeatriz Montero

Hospital Universitario Ramón y Cajal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026