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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of the 6-month period after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | All-cause mortality will be determined in a 6-month period by using information from the electronic health records. | From enrollment to the end of the 6-month period after hospital discharge. |
| Hospitalization for any cause |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Alberto Pérez Nieva | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Beatriz Montero | Hospital Universitario Ramón y Cajal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ramon y Cajal | Recruiting | Madrid | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33852110 | Background | 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. | |
| 36633611 | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Serum and plasma
Hospitalizations for any cause in a 6-month period will be recorded by review of the electronic health records.
| From enrollment to the end of the 6-month period after hospital discharge. |
| 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. | From enrollment to the end of the 6-month period after hospital discharge. |
| 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. | From enrollment to the end of the 6-month period after hospital discharge. |
| 38831963 | 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. |
| 38337720 | 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. |
| 38520141 | 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. |
| 38135146 | 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. |
| 32829921 | 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |