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NCT Number: NCT07530029

Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

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.

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Key information

Conditions

Acute Heart Failure (AHF) Atrophy Cardiovascular Diseases Heart Diseases Heart Failure Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location status: Recruiting

Location contact

Alberto Perez-Nieva

CONTACT

[email protected]

0034913368000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite outcome of all-cause mortality and worsening heart failure

    Time frame: From 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 outcomes

  1. All cause mortality

    Time frame: From 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.

  2. Hospitalization for any cause

    Time frame: From 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.

  3. Emergency room (ER) visits for heart failure

    Time frame: From 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.

  4. Need for intravenous diuretics in a Heart Failure Unit visit

    Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Pérez-Nieva, MD

CONTACT

[email protected]

+34 913 36 80 00

Cristina Fernández Soler

CONTACT

[email protected]

+34 913 36 80 00

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Acronym: MUSICA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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