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

NCT07266012 | Completed

• 1 other identifier: 2025/618IUCIC
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension (PAH); Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Keywords

VExUS; Pulmonary Arterial Hypertension; Risk Stratification; Venous Congestion; Right Ventricular Function; doppler ultrasound

Outcome Measures

Primary Outcomes (1)

• Correlation Between the VExUS Score and Invasive Haemodynamic Parameters

  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).

  At the single study visit (Day 0)

Secondary Outcomes (4)

• 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

• Incremental Contribution of the VExUS Score to ESC/ERS Four-Strata Risk Classification

  Day 0

Study Arms (1)

PAH Cohort

Adults with World Health Organization (WHO) Group 1 pulmonary arterial hypertension undergoing non-invasive assessment with the Venous Excess Ultrasound Score (VEXUS) and the ESC/ERS 2022 simplified four-strata risk model during routine clinical follow-up. No intervention is administered; this is an observational cohort with a single study visit in which VEXUS, 6MWT, BNP, WHO-FC and recent haemodynamic parameters are collected.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients diagnosed with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who are being followed at a tertiary pulmonary hypertension centre. Participants represent a real-world cohort of clinically stable PAH patients attending routine outpatient follow-up visits. All participants undergo non-invasive assessment including VEXUS ultrasonography, 6-minute walk test (6MWT), WHO functional class evaluation, and BNP measurement at the study visit. Recent right and/or left heart catheterisation data (performed within ±2 months for standard clinical indications) are collected from medical records. Patients with other forms of pulmonary hypertension, Eisenmenger syndrome, pulmonary veno-occlusive disease, or pulmonary capillary haemangiomatosis are excluded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Cardiology

Istanbul, FATIH, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.

  PMID: 32270297 RESULT

• Boucly A, Weatherald J, Savale L, Jais X, Cottin V, Prevot G, Picard F, de Groote P, Jevnikar M, Bergot E, Chaouat A, Chabanne C, Bourdin A, Parent F, Montani D, Simonneau G, Humbert M, Sitbon O. Risk assessment, prognosis and guideline implementation in pulmonary arterial hypertension. Eur Respir J. 2017 Aug 3;50(2):1700889. doi: 10.1183/13993003.00889-2017. Print 2017 Aug.

  PMID: 28775050 RESULT

• Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618-3731. doi: 10.1093/eurheartj/ehac237. No abstract available.

  PMID: 36017548 RESULT

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hyperemia

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SAHRA ASENA BALCIOGLU, MD

  ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Cardiology Department

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 5, 2025
• Study Start: May 7, 2025
• Primary Completion: November 5, 2025
• Study Completion: November 21, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 12 months after publication of the primary manuscript and for up to 3 years thereafter.
• Access Criteria: Requests must be submitted in writing to the principal investigator. Data will be provided only for methodologically sound proposals and after review by the institutional data governance committee. A data use agreement (DUA) will be required.

Locations

TU (1)