Multimodal Approach to Sarcopenia and Its Prognostic Impact in Older Patients Hospitalized for Acute Heart Failure (MUSICA Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Composite outcome of all-cause mortality and worsening heart failure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •End-of-life care.
- •Inability to comply with study procedures.
- •Already included patients on readmission.
结局指标
主要结局
Composite outcome of all-cause mortality and worsening heart failure
时间窗: From enrollment to the end of the 6 month period after hospital discharge.
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.
次要结局
- 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.)