Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

NCT07530029 | Not Yet Recruiting

• 1 other identifier: IMP-25/C14
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Heart Failure (AHF); Sarcopenia; Heart Failure

Keywords

biomarkers; point of care ultrasound (POCUS); Acute Heart Failure (AHF); Sarcopenia

Outcome Measures

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 six 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.

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

Secondary Outcomes (4)

• All cause mortality

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

• Hospitalization for any cause

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

• Emergency room (ER) visits for heart failure

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

• Need for iv diuretics in a Heart Failure Unit visit

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

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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 echocardiogram, and elevated natriuretic peptides. Only patients with LVEF ≥50% (preserved) will be included.

You may qualify if:

• 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 echocardiogram (performed during admission or within a period of 24 months prior to admission).
• Age ≥ 80 years.
• NYHA functional class II-IV.

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (7)

• Castiglione V, Aimo A, Vergaro G, Saccaro L, Passino C, Emdin M. Biomarkers for the diagnosis and management of heart failure. Heart Fail Rev. 2022 Mar;27(2):625-643. doi: 10.1007/s10741-021-10105-w. Epub 2021 Apr 14.

  PMID: 33852110 BACKGROUND

• Ladang A, Beaudart C, Reginster JY, Al-Daghri N, Bruyere O, Burlet N, Cesari M, Cherubini A, da Silva MC, Cooper C, Cruz-Jentoft AJ, Landi F, Laslop A, Maggi S, Mobasheri A, Ormarsdottir S, Radermecker R, Visser M, Yerro MCP, Rizzoli R, Cavalier E. Biochemical Markers of Musculoskeletal Health and Aging to be Assessed in Clinical Trials of Drugs Aiming at the Treatment of Sarcopenia: Consensus Paper from an Expert Group Meeting Organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the Centre Academique de Recherche et d'Experimentation en Sante (CARES SPRL), Under the Auspices of the World Health Organization Collaborating Center for the Epidemiology of Musculoskeletal Conditions and Aging. Calcif Tissue Int. 2023 Feb;112(2):197-217. doi: 10.1007/s00223-022-01054-z. Epub 2023 Jan 12.

  PMID: 36633611 BACKGROUND

• Staempfli JS, Kistler-Fischbacher M, Gewiess J, Bastian JD, Eggimann AK. The Validity of Muscle Ultrasound in the Diagnostic Workup of Sarcopenia Among Older Adults: A Scoping Review. Clin Interv Aging. 2024 May 30;19:993-1003. doi: 10.2147/CIA.S463917. eCollection 2024.

  PMID: 38831963 BACKGROUND

• Voulgaridou G, Tyrovolas S, Detopoulou P, Tsoumana D, Drakaki M, Apostolou T, Chatziprodromidou IP, Papandreou D, Giaginis C, Papadopoulou SK. Diagnostic Criteria and Measurement Techniques of Sarcopenia: A Critical Evaluation of the Up-to-Date Evidence. Nutrients. 2024 Feb 1;16(3):436. doi: 10.3390/nu16030436.

  PMID: 38337720 BACKGROUND

• Kirk B, Cawthon PM, Arai H, Avila-Funes JA, Barazzoni R, Bhasin S, Binder EF, Bruyere O, Cederholm T, Chen LK, Cooper C, Duque G, Fielding RA, Guralnik J, Kiel DP, Landi F, Reginster JY, Sayer AA, Visser M, von Haehling S, Woo J, Cruz-Jentoft AJ; Global Leadership Initiative in Sarcopenia (GLIS) group. The Conceptual Definition of Sarcopenia: Delphi Consensus from the Global Leadership Initiative in Sarcopenia (GLIS). Age Ageing. 2024 Mar 1;53(3):afae052. doi: 10.1093/ageing/afae052.

  PMID: 38520141 BACKGROUND

• Sato K, Kamiya K, Hamazaki N, Nozaki K, Ichikawa T, Uchida S, Ueno K, Yamashita M, Noda T, Ogura K, Miki T, Hotta K, Maekawa E, Yamaoka-Tojo M, Matsunaga A, Ako J. Association of sarcopenia defined by different skeletal muscle mass measurements with prognosis and quality of life in older patients with heart failure. J Cardiol. 2024 Jul;84(1):59-64. doi: 10.1016/j.jjcc.2023.12.003. Epub 2023 Dec 21.

  PMID: 38135146 BACKGROUND

• Trullas JC, Perez-Calvo JI, Conde-Martel A, Llacer Iborra P, Suarez Pedreira I, Ormaechea G, Soler Rangel L, Gonzalez Franco A, Cepeda JM, Montero-Perez-Barquero M; en representacion de los investigadores del registro RICA. Epidemiology of heart failure with preserved ejection fraction: Results from the RICA Registry. Med Clin (Barc). 2021 Jul 9;157(1):1-9. doi: 10.1016/j.medcli.2020.05.059. Epub 2020 Aug 21. English, Spanish.

  PMID: 32829921 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Sarcopenia; Heart Failure

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Alberto Pérez Nieva

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

• Beatriz Montero

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Pérez-Nieva, MD

CONTACT

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

Cristina Fernández Soler

CONTACT

+34 913 36 80 00; cfsoler@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

ES (1)