通过FibroScan®评估肝脏硬度性能以检测升高的中心静脉压（CVP）
通过FibroScan®进行的肝脏硬度测量（LSM）对诊断中心静脉压（CVP）升高的性能
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.
研究概览
地位
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：CAROLE MEILLEROUX, PharmD
- 电话号码：+33622649277
- 邮箱：carole.meilleroux@echosens.com
学习地点
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Berlin、德国、13353
- 招聘中
- Deutsches Herzzentrum der Charité (DHZC) - Klinik fuer Herz-, Thorax- und Gefaesschirurgie
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接触：
- Felix Schoenrath, MD
- 电话号码：4.93046E+11
- 邮箱：felix.schoenrath@dhzc-charite.de
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Ile Et Vilaine
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Rennes、Ile Et Vilaine、法国、35000
- 招聘中
- Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou
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接触：
- Erwan Donal, MD
- 电话号码：33617708567
- 邮箱：erwan.donal@chu-rennes.fr
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Basse-Silésie
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Wroclaw、Basse-Silésie、波兰
- 招聘中
- Uniwersytet Medyczny im. Piastow Slaskich we Wroclawiu, Instytut Chorob Serca
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接触：
- Jan Biegus, MD
- 电话号码：48606674114
- 邮箱：janbiegus@gmail.com
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California
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Los Angeles、California、美国、90033
- 尚未招聘
- Keck Medicine of USC-Norris Healthcare Center - Transplant Clinic
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接触：
- Michael Fong, MD
- 邮箱：michael.fong@usc.edu
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Minnesota
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Minneota、Minnesota、美国、55455
- 招聘中
- University of Minnesota
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接触：
- Tamas Alexy, MD
- 电话号码：612-626-1240
- 邮箱：alexy001@umn.edu
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South Carolina
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Charleston、South Carolina、美国、29425
- 招聘中
- Medical University of South Carolina
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接触：
- Michele Esposito, MD
- 电话号码：843-792-1105
- 邮箱：espositm@musc.edu
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Texas
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Dallas、Texas、美国、75390
- 招聘中
- University of Texas Southwestern Medical Center - Clinical Heart and Vascular Center - West Campus Building 3 Location
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接触：
- Ambarish Pandey, MD, MSCS, FAHA
- 电话号码：214-645-2101
- 邮箱：ambarish.pandey@utsouthwestern.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Ascites
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Full Cohort
This population will be defined by patients fulfilling all inclusion and exclusion criteria. |
At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM) at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP) at Day 0 assessment of cardiac function At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of individuals with elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Sensitivity]
大体时间：at Day 0
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Sensitivity (true positive rate) = TP / (TP + FN) |
at Day 0
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Proportion of individuals without elevated CVP (>10 mm Hg) who are correctly identified by LSM (cutoff of 13.3 kPa) [Specificity]
大体时间：at Day 0
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Specificity (1 - false negative rate) = TN / (TN + FP) |
at Day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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通过LSM（约登指数）正确识别中心静脉压升高（>10毫米汞柱）诊断的个体比例
大体时间：第0天
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第0天
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通过LSM（约登指数）正确识别下腔静脉直径异常个体的比例
大体时间：在第 0 天
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在第 0 天
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逻辑回归模型用于识别与LSM/CVP不一致相关的临床、实验室和超声心动图因素。
大体时间：第0天时
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第0天时
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采用DeLong检验对相关ROC曲线进行比较，评估LSM、超声心动图参数和NT-proBNP在正确识别中心静脉压升高（>10 mm Hg）诊断个体中的比例
大体时间：在第0天
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在第0天
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Correlation between LSM and echocardiographic parameters evaluated with Pearson or Spearman correlation coefficients
大体时间：at Day 0
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at Day 0
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Correlation between LSM and NT-proBNP evaluated with Pearson or Spearman correlation coefficients
大体时间：at Day 0
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at Day 0
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Correlation between LSM and CA-125 evaluated with Pearson or Spearman correlation coefficients
大体时间：at Day 0
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at Day 0
|
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Correlation between LSM and clinical parameters evaluated with Pearson or Spearman correlation coefficients
大体时间：at Day 0
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at Day 0
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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出现至少一种不良事件的患者人数
大体时间：7天
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7天
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合作者和调查者
赞助
合作者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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