Pulmonary Arterial Hypertension (PAH)INVEXUS-PAHNCT07266012
Incorporating the Venous Excess Ultrasound Score (VExUS Score) Into Contemporary Haemodynamic Risk Assessment in Pulmonary Arterial Hypertension: The INVEXUS-PAH Study
An observational study of Pulmonary Arterial Hypertension (PAH) and Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2025to 21 Nov 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Institute of Cardiology
Istanbul, FATIH, 34098
About this 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.
Read the 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.
- 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
- Medical subject headings
- Pulmonary Arterial Hypertension, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the single study visit (Day 0)
Secondary outcomes (4)
Correlation Between the VExUS Score and Non-Invasive Clinical Markers
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.
Measured: Day 0
Correlation Between the VExUS Score and Echocardiographic RV-PA Coupling Indices
Correlation between the VExUS Score and tricuspid annular plane systolic excursion (TAPSE; mm) and the TAPSE/systolic pulmonary artery pressure ratio (unitless).
Measured: Day 0
Predictive Value of the VExUS Score for Elevated Pulmonary Vascular Resistance (≥ 6 Wood Units)
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.
Measured: Day 0
Incremental Contribution of the VExUS Score to ESC/ERS Four-Strata Risk Classification
Change in ESC/ERS simplified four-strata risk category after incorporation of the VExUS Score, including net reclassification and risk-category shifts.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start7 May 2025
- Primary completion5 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahra Asena Balcioglu, Istanbul University - Cerrahpasa
- Investigators
- SAHRA ASENA BALCIOGLU, MD, Principal investigator, ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266012
- Sponsor's protocol ID
- 2025/618IUCIC
- Acronym
- INVEXUS-PAH
- Status last verified
- Jun 2025
- First submitted
- 23 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32270297Boucly 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.
PubMed 28775050Humbert 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.
PubMed 36017548
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating the Venous Excess Ultrasound Score (VExUS Score) Into Contemporary Haemodynamic Risk Assessment in Pulmonary Arterial Hypertension: The INVEXUS-PAH Study
- ClinicalTrials.gov ID
- NCT07266012
- Acronym / sponsor ID
- INVEXUS-PAH / 2025/618IUCIC
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- Pulmonary hypertension other than WHO Group 1, including:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Correlation Between the VExUS Score and Non-Invasive Clinical Markers
Time frame: Day 0
Correlation Between the VExUS Score and Echocardiographic RV-PA Coupling Indices
Time frame: Day 0
Predictive Value of the VExUS Score for Elevated Pulmonary Vascular Resistance (≥ 6 Wood Units)
Time frame: Day 0
Incremental Contribution of the VExUS Score to ESC/ERS Four-Strata Risk Classification
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 32270297Beaubien-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.
- Results publication: PubMed 28775050Boucly 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.
- Results publication: PubMed 36017548Humbert 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAHRA ASENA BALCIOGLU, MD principal investigator
ISTANBUL UNIVERSITY-CERRAHPASA INSTITUTE OF CARDIOLOGY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension (PAH) and Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between the VExUS Score and Invasive Haemodynamic Parameters (time frame: At the single study visit (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07266012, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.