NCT05411263终止不适用
Portal Vein Flow Variability to Quantify Right-Sided Hemodynamic Congestion: A Proof-Of-Concept Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Portal Vein Pulsatility Index (PVPI)
研究概览
简要总结
This study evaluates the accuracy of a comprehensive venous Doppler echography including the portal vein pulsatility index (PVPI) to quantify invasively measured right-sided venous pressures. A substudy will correlate invasive and non-invasive hemodynamic measurements to ballistocardiography and seismocardiography with the Kino-cardiograph (Kino) device (HeartKinetics, Waterloo, Belgium).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 year old and able to provide informed consent;
- •Consecutive patients scheduled for right heart catheterisation by a dedicated heart failure specialist at the Centre of Cardiovascular Diseases (University Hospital Brussels, Jette, Belgium).
排除标准
- •Major anatomical variations of the portal veins (agenesis of left and right portal vein) and/or arterio-portal vein fistula;
- •Patients with Child-Pugh B or C liver cirrhosis or liver transplant;
- •Body Mass Index < 20 kg/m².
结局指标
主要结局
Portal Vein Pulsatility Index (PVPI)
时间窗: Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam
PVPI = (Vmax - Vmin)/Vmax on the portal vein Pulsed wave Doppler signal
次要结局
- Time integral of kinetic energy during the cardiac cycle(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Inferior vena cava diameter(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Inferior vena cava diameter respiratory variation(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Hepatic vein Pulsed wave Doppler signal(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Renal vein Pulsed wave Doppler signal(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Right ventricular (RV) free wall strain(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
- Right atrial strain(Crosssectional study without longitudinal follow-up, measurement is obtained during Doppler echography exam)
研究者
Frederik Hendrik Verbrugge, MD PhD MSc
Clinical Professor/Head of Clinic
Universitair Ziekenhuis Brussel
研究点 (2)
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