Incorporating the Venous Excess Ultrasound Score (VExUS Score) Into Contemporary Haemodynamic Ris… (NCT07266012) | Clinical Trial Compass
CompletedNot Applicable
Incorporating the Venous Excess Ultrasound Score (VExUS Score) Into Contemporary Haemodynamic Risk Assessment in Pulmonary Arterial Hypertension: The INVEXUS-PAH Study
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Adults aged ≥18 years
* Established diagnosis of WHO Group 1 pulmonary arterial hypertension (PAH)
* Stable outpatient clinical status at the time of VExUS ultrasonography
* Venous Excess Ultrasound Score (VExUS) evaluation performed with adequate ultrasonographic acoustic windows
* Clinically indicated right heart catheterisation (RHC) performed within ±60 days of VExUS assessment
* Availability of ESC/ERS 2022 simplified risk assessment variables (WHO functional class, BNP/NT-proBNP, and 6-minute walk distance)
* Ability to provide written informed consent
Exclusion Criteria
* Pulmonary hypertension other than WHO Group 1, including:
* PH due to left heart disease (WHO Group 2)
* PH due to chronic lung disease or hypoxaemia (WHO Group 3)
* Chronic thromboembolic pulmonary hypertension (CTEPH; WHO Group 4)
* Multifactorial PH (WHO Group 5)
* Eisenmenger syndrome
* Complex or unrepaired congenital heart disease
* Suspected pulmonary veno-occlusive disease (PVOD)
* Pulmonary capillary haemangiomatosis (PCH)
* Acute decompensated right heart failure
* Severe renal dysfunction (eGFR \<30 mL/min/1.73 m²)
* Severe hepatic impairment (Child-Pugh Class C)
* Congestive hepatopathy
* Active infection
* Pregnancy
* Inability or unwillingness to provide informed consent
* Poor ultrasonographic acoustic window preventing adequate VExUS scoring
What they're measuring
1
Correlation Between the VExUS Score and Invasive Haemodynamic Parameters