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

December 6, 2025 updated by: Sahra Asena Balcioglu, Istanbul University - Cerrahpasa
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • FATIH
      • Istanbul, FATIH, Turkey (Türkiye), 34098
        • Istanbul University-Cerrahpasa Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation Between the VExUS Score and Invasive Haemodynamic Parameters
Time Frame: 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).
At the single study visit (Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between the VExUS Score and Non-Invasive Clinical Markers
Time Frame: Day 0
Correlation between the VExUS Score and serum B-type natriuretic peptide (BNP; pg/mL), WHO functional class (4-level ordinal scale) and six-minute walk distance (metres), which form key components of current ESC/ERS risk stratification models.
Day 0
Correlation Between the VExUS Score and Echocardiographic RV-PA Coupling Indices
Time Frame: Day 0
Correlation between the VExUS Score and tricuspid annular plane systolic excursion (TAPSE; mm) and the TAPSE/systolic pulmonary artery pressure ratio (unitless).
Day 0
Predictive Value of the VExUS Score for Elevated Pulmonary Vascular Resistance (≥ 6 Wood Units)
Time Frame: Day 0
Evaluation of the predictive performance of the VExUS Score for identifying patients with elevated pulmonary vascular resistance (≥ 6 Wood units). Predictive metrics (including odds ratios) will be reported.
Day 0
Incremental Contribution of the VExUS Score to ESC/ERS Four-Strata Risk Classification
Time Frame: Day 0
Change in ESC/ERS simplified four-strata risk category after incorporation of the VExUS Score, including net reclassification and risk-category shifts.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SAHRA ASENA BALCIOGLU, MD, Istanbul University-Cerrahpasa Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/618IUCIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only de-identified individual participant data (IPD) related to primary and secondary outcome measures may be shared with qualified researchers upon reasonable request. No direct identifiers or protected health information will be released.

IPD Sharing Time Frame

Beginning 12 months after publication of the primary manuscript and for up to 3 years thereafter.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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