An observational study in Pulmonary Arterial Hypertension (PAH) and Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Istanbul University - Cerrahpasa · Observational
Among 31 studies in Pulmonary Arterial Hypertension with a site in Turkey — 4 open to participants now, 7 under way, 3 of them phase 3. Pulmonary Arterial Hypertension · Turkey.
Among the 31 studies in Pulmonary Arterial Hypertension with a site in Turkey, this one is the only one that started in 2025, is one of 7 observational ones, and was the 30th registered.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's enrollment of 86 is below the median of 104 across 181 observational studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →4 of the 31 studies in Pulmonary Arterial Hypertension with a site in Turkey are open now, in 12 countries. Each count lists the studies.
Of the 90 Pulmonary Arterial Hypertension studies recruiting now, 51 (57%) set no upper age limit and 24 (27%) stop at 75 or younger; 18 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2025.
Median enrollment 185 across the 24 interventional studies, 61 across the 7 observational. Of the 24 that completed or were terminated, 12 (50%) have results posted.
20 of 31 have an industry lead sponsor. The 10 most frequent:
Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
Istanbul University - Cerrahpasa has 4 studies filed under Pulmonary Arterial Hypertension — fewer than ten, so there is no comparison to draw.
2 of the studies in Pulmonary Arterial Hypertension with a site in Turkey that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT07667673Istanbul University - CerrahpasaMultimodality RV Phenotyping for Risk Stratification and Short-Term Outcomes in Group 1 PAH | 2027-02 |
Among the 31 studies in Pulmonary Arterial Hypertension with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Pulmonary hypertension other than WHO Group 1, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: At the single study visit (Day 0)
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 0
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
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.
Ran from May 2025 to primary completion in Nov 2025, 5 months.
Of 64 non-industry observational studies under Pulmonary Arterial Hypertension, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 31. This study's 5 months is below that.
Counting every sponsor, half of 85 studies reached it within 58 months; a quarter within 30 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension →
Istanbul University - Cerrahpasa →