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NCT07266012Completed

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

Source: ClinicalTrials.gov · Last updated 15 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
86 (actual)
First submitted
23 Nov 2025
Start date
7 May 2025
Primary completion date
5 Nov 2025
Lead sponsor
Istanbul University - Cerrahpasa
NCT number
NCT07266012

What you commit to

  • Study type: Observational
  • Participants enrolled: 86
  • From 7 May 2025 to the primary completion date, 5 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)
  • Acute decompensated right heart failure
  • Severe hepatic impairment (Child-Pugh Class C)
  • Active infection

Lab values

  • Severe renal dysfunction (eGFR \<30 mL/min/1.73 m²)

Other

  • Pulmonary capillary haemangiomatosis (PCH)
  • Congestive hepatopathy
  • Pregnancy
  • Inability or unwillingness to provide informed consent
  • Poor ultrasonographic acoustic window preventing adequate VExUS scoring

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istanbul University Cerrahpaşa Institute of Cardiology
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.