Performance of Liver Stiffness Measurement (LSM) by FibroScan® for the Diagnosis of Elevated Central Venous Pressure (CVP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Echosens
- 入组人数
- 149
- 试验地点
- 7
- 主要终点
- Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]
研究概览
简要总结
This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.
详细描述
CHF, as defined by the American College of Cardiology and the American Heart Association, is "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood." These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of congestive symptoms by days resulting in hepatic congestion.
Invasive methods, such as RHC, remain the gold standard method of measuring CVP, offering accurate and direct hemodynamic data. However, RHC requires specialized training and invasive vascular access and is associated with procedural risks including bleeding, infection, arrhythmia, and patient discomfort.
Echocardiography is the most common non-invasive adjunct tool for estimating CVP and assessing cardiac function. It evaluates indirect parameters, right atrial size, IVC diameter, and collapsibility to detect elevated CVP.
LSM by VCTE™ has emerged as a novel non-invasive approach to detecting elevated CVP indirectly. Liver elastography relies on imaging techniques to assess LSM, with high values equating to increased stiffness. While this was developed to assess fibrosis in chronic liver diseases, LSM also reflects increased CVP and hepatic congestion. Multiple studies have shown promising correlations between increased liver stiffness and invasively measured CVP, indicating a potential clinical strategy for detecting hemodynamic congestion non-invasively.
Given these considerations, the current clinical investigation aims to evaluate the 13.3 kPa cutoff performance of LSM with FibroScan (Echosens, Paris, France) to diagnose elevated CVP (>10 mm Hg).
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
盲法说明
To minimize bias in clinical performance evaluation, the participant and operator of the device under test will be blinded to the clinical reference standard (ie, CVP as assessed by invasive hemodynamic catheter) result.
The FibroScan operator will not be the same as the hemodynamic catheterization operator.
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
- •Have read, understood, and signed the informed consent form (ICF)
- •Be ≥18 years of age at the time of screening
- •Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization
排除标准
- •Inability to consent
- •Chronic liver disease (self-reported alcohol use >14 drinks/week in females and >21 drinks/week in males), positive hepatitis C virus serology, positive hepatitis B surface antigen, autoimmune hepatitis, hemochromatosis, or cholestatic disease)
- •BMI >40 kg/m2
- •Fontan-type circulation
- •Heart transplantation
- •Pregnancy, breastfeeding, or intent to become pregnant during the study
- •Intent to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study
研究组 & 干预措施
Full Cohort
This population will be defined by patients fulfilling all inclusion and exclusion criteria.
干预措施: FibroScan (Device)
Full Cohort
This population will be defined by patients fulfilling all inclusion and exclusion criteria.
干预措施: Right-sided Heart Catheterization (Procedure)
Full Cohort
This population will be defined by patients fulfilling all inclusion and exclusion criteria.
干预措施: Transthoracic echocardiography (Procedure)
Full Cohort
This population will be defined by patients fulfilling all inclusion and exclusion criteria.
干预措施: Blood Sample Analysis (Biological)
结局指标
主要结局
Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]
时间窗: at Day 0
Sensitivity (true positive rate) = TP / (TP + FN)
Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]
时间窗: at Day 0
Specificity (1 - false negative rate) = TN / (TN + FP)
次要结局
- Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients(at Day 0)
- Logistic regression model to identify clinical, laboratory, and echocardiographic factors associated with LSM/CVP discordance.(at Day 0)
- Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of elevated CVP (>10 mm Hg)(at Day 0)
- Proportion of individuals correctly identified by LSM (Youden index) for the diagnosis of abnormal IVC diameter(at Day 0)
- Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients(at Day 0)
- Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients(at Day 0)
- Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients(at Day 0)
- Proportion of individuals correctly identified for the diagnosis of elevated CVP (>10 mm Hg) compared between LSM, echocardiography parameter and NT-proBNP using DeLong's test for correlated ROC curves(at Day 0)