Sarcopenia in Older Patients Hospitalized for Acute Heart Failure.

Официальное название

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

Обзор

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.

Первичные конечные точки

• Composite outcome of all-cause mortality and worsening heart failure [Срок оценки: From enrollment to the end of the 6-month period after hospital discharge.]

Вторичные конечные точки (4)

• All cause mortality [Срок оценки: From enrollment to the end of the 6-month period after hospital discharge.]
• Hospitalization for any cause [Срок оценки: From enrollment to the end of the 6-month period after hospital discharge.]
• Emergency room (ER) visits for heart failure [Срок оценки: From enrollment to the end of the 6-month period after hospital discharge.]
• Need for intravenous diuretics in a Heart Failure Unit visit [Срок оценки: From enrollment to the end of the 6-month period after hospital discharge.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Universitario Ramon y Cajal — Madrid

Публикации

• 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
• 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 Pap PMID 36633611
• 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
• 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
• 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 PMID 38520141
• 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
• 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 PMID 32829921

Идентификаторы

NCT: NCT07530029 · IMP-25/C14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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