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临床试验/NCT07266012
NCT07266012已完成不适用

Incorporating the Venous Excess Ultrasound Score (VExUS Score) Into Contemporary Haemodynamic Risk Assessment in Pulmonary Arterial Hypertension: The INVEXUS-PAH Study

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年5月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Correlation Between the VExUS Score and Invasive Haemodynamic Parameters

研究概览

简要总结

This prospective observational study aims to evaluate the relationship between the Venous Excess Ultrasound Score (VEXUS) and the ESC/ERS 2022 simplified four-strata risk assessment model in adult patients with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH). The study investigates whether VEXUS can enhance risk stratification and predict haemodynamic congestion by correlating VEXUS with functional, biochemical, and invasive haemodynamic parameters.

详细描述

Pulmonary arterial hypertension (PAH) is a progressive disorder characterised by increased pulmonary vascular resistance, right ventricular overload, systemic venous congestion, and high mortality. The ESC/ERS 2022 simplified four-strata model (low, intermediate-low, intermediate-high, high risk) guides treatment decisions using WHO functional class, 6-minute walk distance, and BNP/NT-proBNP levels.

However, biochemical markers may be costly or insufficiently sensitive to early haemodynamic deterioration.

VEXUS (Venous Excess Ultrasound Score), a point-of-care ultrasonographic method assessing hepatic, portal, and renal venous Doppler patterns, has shown promise in representing venous congestion.

This study evaluates whether VEXUS correlates with ESC/ERS risk categories and invasive haemodynamic parameters including right atrial pressure, mean pulmonary arterial pressure, pulmonary vascular resistance, cardiac output, and pulmonary output. The study further aims to explore whether integrating VEXUS into PAH follow-up may strengthen risk assessment.

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation Between the VExUS Score and Invasive Haemodynamic Parameters

时间窗: At the single study visit (Day 0)

Correlation between the VExUS Score (0-3 Doppler-based venous congestion score) and invasive haemodynamic measurements obtained by right heart catheterisation, including pulmonary vascular resistance (PVR; Wood units), right atrial pressure (RAP; mmHg), Fick-derived cardiac output (L/min) and pulmonary blood flow (PBF; L/min).

次要结局

  • Incremental Contribution of the VExUS Score to ESC/ERS Four-Strata Risk Classification(Day 0)
  • Correlation Between the VExUS Score and Non-Invasive Clinical Markers(Day 0)
  • Correlation Between the VExUS Score and Echocardiographic RV-PA Coupling Indices(Day 0)
  • Predictive Value of the VExUS Score for Elevated Pulmonary Vascular Resistance (≥ 6 Wood Units)(Day 0)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahra Asena Balcioglu

Resident Physician, Cardiology Department

Istanbul University - Cerrahpasa

研究点 (1)

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