Validation of a Combined Score Combining the Lung Ultrasound Score and Lactate at Discharge for Predicting Early Events After Acute Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Composite of heart failure-related readmission or all-cause mortality
研究概览
简要总结
Acute heart failure (AHF) is a leading cause of hospitalization and is associated with high short-term morbidity and mortality, with 20-30% of patients experiencing rehospitalization or death within 30 days. Early adverse events often reflect incomplete recovery, highlighting the need for improved risk stratification after clinical stabilization .Current prognostic approaches mainly focus on hemodynamic congestion. Persistent pulmonary congestion at discharge is a strong predictor of poor outcomes, but these markers primarily assess macrocirculatory abnormalities and do not capture microcirculatory dysfunction, which may persist despite apparent clinical improvement. Lung ultrasound, through the Lung Ultrasound Score (LUS), provides a validated assessment of pulmonary congestion and has demonstrated prognostic value in AHF. However, LUS does not reflect systemic tissue perfusion. In contrast, blood lactate is a robust marker of tissue hypoperfusion, and even mild elevations have been associated with worse outcomes in AHF. A combined score integrating LUS and lactate may therefore better reflect the dual pathophysiology of AHF-persistent congestion and impaired tissue perfusion-and improve prediction of early adverse events.
This protocol aims to validate the prognostic value of this combined score for predicting 30-day rehospitalization or death in patients hospitalized for AHF, with the hypothesis that it outperforms LUS alone.
详细描述
This is a prospective, multicenter, observational cohort study including adults (≥18 years) hospitalized for acute decompensated heart failure who were deemed clinically stable and scheduled for discharge within 24 hours. Patients with active severe infection or septic shock, significant hypoxemia or respiratory distress requiring advanced oxygen or ventilatory support, advanced liver disease, refusal to participate, or technical inability to perform lung ultrasound were excluded. At discharge, pulmonary congestion was assessed using lung ultrasound with a standardized 8-zone protocol, and venous blood lactate was measured under resting conditions. Demographic data, heart failure phenotype, discharge vital signs, laboratory values, treatments, and hospitalization characteristics were collected. The primary endpoint was a composite of heart failure-related readmission or all-cause mortality within 30 days after discharge. Secondary endpoints included all-cause readmission, emergency department visits at 30 days, and time to first event. Follow-up was conducted at 30 days using a standardized telephone interview and review of medical records, with strict criteria applied for the definition of heart failure readmission.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Hospitalization for acute heart failure/decompensation (clinical diagnosis + imaging/laboratory tests according to local practice).
- •Patient deemed ready for discharge (decision made by the team, discharge within 24 hours).
排除标准
- •Septic shock/severe active infection at the time of discharge.
- •Hypoxemia or respiratory distress requiring high-flow oxygen/ventilation at the scheduled time of discharge.
- •Severe cirrhosis/advanced liver failure.
- •Refusal to participate.
- •Technical impossibility of LUS.
研究组 & 干预措施
Integrated LUS-Lactate Risk Group
Patients classified according to a combined assessment of pulmonary congestion measured by lung ultrasound (LUS) and systemic tissue perfusion reflected by blood lactate levels at hospital discharge, aiming to capture both residual congestion and microcirculatory dysfunction and to improve prediction of early adverse outcomes.
干预措施: Lactate Blood Test (Diagnostic Test)
Integrated LUS-Lactate Risk Group
Patients classified according to a combined assessment of pulmonary congestion measured by lung ultrasound (LUS) and systemic tissue perfusion reflected by blood lactate levels at hospital discharge, aiming to capture both residual congestion and microcirculatory dysfunction and to improve prediction of early adverse outcomes.
干预措施: Lung Ultrasound Score (Diagnostic Test)
结局指标
主要结局
Composite of heart failure-related readmission or all-cause mortality
时间窗: 30 days after hospital discharge
A combined outcome of heart failure-related rehospitalization or all-cause death within 30 days after hospital discharge, used to assess early adverse events in acute heart failure patients.
次要结局
- Time to first event(At 30 days)
研究者
Pr. Semir Nouira
Professor
University of Monastir