Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The Area under the Receiving Operator Characteristic curve (AUC ROC) of Liver Stiffness Measurement (LSM) value to diagnose AHF. Other diagnostic performances will also be assessed at the threshold determined by Youden's method.
研究概览
简要总结
Acute heart failure (AHF) is a major cause of acute dyspnea in emergency departments (EDs), driven primarily by venous congestion, which can lead to hepatic congestion and risk of subsequent liver dysfunction. Current diagnostic tools include clinical evaluation, biomarkers, and imaging (Chest X-Ray or echography), are often limited by delayed results, variability, and suboptimal accuracy in emergency settings.
Fibroscan®, a non-invasive device originally designed to assess liver stiffness in chronic liver conditions, has shown potential in detecting liver congestion linked to heart failure. Studies have highlighted significant correlations between liver stiffness measurements (LSM) and markers of venous congestion, such as central venous pressure and adverse outcomes in heart failure patients. Preliminary findings suggest that LSM could provide rapid, bedside insights into systemic congestion, offering a promising avenue for improving diagnostic workflows in acute care.
While prior research has mainly focused on chronic heart failure or small study populations, further investigation is needed to explore the utility of Fibroscan® in acute presentations of AHF within EDs. This could help address the limitations of existing diagnostic approaches and enhance patient management in time-sensitive environments.
详细描述
Acute heart failure (AHF) is a major cause of acute dyspnea in emergency departments (EDs), driven primarily by venous congestion, which can lead to hepatic congestion and risk of subsequent liver dysfunction. Current diagnostic tools include clinical evaluation, biomarkers, and imaging (Chest X-Ray or echography), are often limited by delayed results, variability, and suboptimal accuracy in emergency settings.
Fibroscan®, a non-invasive device originally designed to assess liver stiffness in chronic liver conditions, has shown potential in detecting liver congestion linked to heart failure. Studies have highlighted significant correlations between liver stiffness measurements (LSM) and markers of venous congestion, such as central venous pressure and adverse outcomes in heart failure patients. Preliminary findings suggest that LSM could provide rapid, bedside insights into systemic congestion, offering a promising avenue for improving diagnostic workflows in acute care.
While prior research has mainly focused on chronic heart failure or small study populations, further investigation is needed to explore the utility of Fibroscan® in acute presentations of AHF within EDs. This could help address the limitations of existing diagnostic approaches and enhance patient management in time-sensitive environments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients ≥18 years
- •ED patients presenting with acute dyspnea and absence of any other obvious cause of dyspnea (for example pneumothorax, acute pneumonia, acute coronary syndrome, Covid) …
- •Social security affiliation (except AME)
- •Informed consent signed
排除标准
- •Known chronic liver disease, defined by a Prothrombic time of < 50%, or any former diagnosis of liver fibrosis.
- •No skin wounds in the abdominal area on which the Fibroscan® will be used
- •History of liver transplantation
- •eGFR <30 mL/min
- •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- •Pregnancy and breastfeeding
- •Participation in another interventional trial
研究组 & 干预措施
Interventional
Patients presenting with acute dyspnea will undergo liver stiffness measurement
干预措施: FibroScan® (Device)
结局指标
主要结局
The Area under the Receiving Operator Characteristic curve (AUC ROC) of Liver Stiffness Measurement (LSM) value to diagnose AHF. Other diagnostic performances will also be assessed at the threshold determined by Youden's method.
时间窗: 28 days after inclusion
次要结局
- Association between the Liver Stiffness Measurement (LSM) and the score of congestion according to a validated clinical congestion score that ranges from 0 to 9.(28 days after inclusion)
