Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age80+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

End-of-life care.

Inability to comply with study procedures.

Already included patients on readmission.

Trial population

Patients over 80 years of age of both sexes hospitalized for AHF in the Internal Medicine or the Geriatrics wards of a tertiary care hospital, with signs of fluid overload and intravenous (IV) diuretic treatment. The clinical diagnosis of HF will be made based on the presence of typical signs and symptoms, evidence of underlying structural heart disease by transthoracic echocardiography, and elevated natriuretic peptides. Only patients with LVEF ≥50% (preserved) will be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Composite outcome of all-cause mortality and worsening heart failure

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.

Time frame
From enrollment to the end of the 6-month period after hospital discharge.

Secondary outcomes

1

All cause mortality

All-cause mortality will be determined in a 6-month period by using information from the electronic health records.

Time frame
From enrollment to the end of the 6-month period after hospital discharge.
2

Hospitalization for any cause

Hospitalizations for any cause in a 6-month period will be recorded by review of the electronic health records.

Time frame
From enrollment to the end of the 6-month period after hospital discharge.
3

Emergency room (ER) visits for heart failure

ER visits for heart failure will be recorded in a 6-month period by reviewing health care electronic records.

Time frame
From enrollment to the end of the 6-month period after hospital discharge.
4

Need for intravenous diuretics in a Heart Failure Unit visit

All episodes of Heart Failure Unit visits requiring intravenous diuretic administration will be recorded by reviewing electronic health records in a 6-month period.

Time frame
From enrollment to the end of the 6-month period after hospital discharge.

Other outcomes

Sponsors and contacts

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