RecruitingNot Applicable

Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

Spain110 participantsStarted 2026-05-05

Plain-language 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.

Who can participate

Age range

80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is specifically looking at both sarcopenia and acute heart failure together — does my situation involve both of these conditions, and is that something my care team has actually assessed?
2Since this trial isn't recruiting yet, how long might it be before it opens, and should I be pursuing other treatment options or studies in the meantime rather than waiting?
3The trial is measuring a combined outcome of death from any cause and worsening heart failure — can you explain what 'worsening heart failure' means in practical terms for someone in my situation, and why tracking both together matters?
4This appears to be an observational or non-interventional study rather than a treatment trial — does that mean participating wouldn't change what treatments I receive, and is there any direct benefit to me personally versus contributing to research?
5Given that sarcopenia, or muscle loss, is part of what's being studied here, should I already be asking about nutrition or physical rehabilitation as part of my heart failure care, regardless of whether I ever join this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite outcome of all-cause mortality and worsening heart failure

Timeframe: From enrollment to the end of the 6-month period after hospital discharge.

Trial details

NCT IDNCT07530029

SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10

Contact for this trial

Alberto Pérez-Nieva, MD

+34 913 36 80 00 apnieva@salud.madrid.org

View on ClinicalTrials.gov More Acute Heart Failure (AHF) trials