NCT07667595

Brief Summary

Pulmonary hypertension (PH) is a hemodynamic and pathophysiological condition defined by a mean pulmonary artery pressure (mPAP) greater than 20 mmHg at rest, as confirmed by right heart catheterization (RHC) (1). The global prevalence of PH is estimated at approximately 1% of the adult population, rising to 10% or more in individuals over 65 years of age.Pre-capillary pulmonary hypertension, which includes pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), is characterized by a pulmonary arterial wedge pressure (PAWP) ≤15 mmHg and an elevated pulmonary vascular resistance (PVR) ≥2 Wood units (2) Computed tomography pulmonary angiography (CTPA) is routinely performed in the diagnostic workup of PH and offers a non invasive alternative that can generate multiple quantitative metrics from a single scan (3). Traditional CTPA metrics, including main pulmonary artery diameter (MPAd), the ratio of MPAd to ascending aortic diameter, central pulmonary arteries, and right ventricular to left ventricular diameter (RV/LV ratio) were previously studied in PH patients (4,5,6) Most existing studies have evaluated CTPA metrics in isolation or within single PH subgroups, limiting generalizability across the broader pre-capillary PH population (7). Therefore, this study aims to systematically investigate the correlation between multiple quantitative CTPA metrics and key invasive hemodynamic parameters derived from RHC in patients with confirmed pre-capillary pulmonary hypertension

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 18, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

CTPA and RHC in precapillary PHTN

Outcome Measures

Primary Outcomes (1)

  • To determine the correlation between CTPA-derived morphometric metrics - specifically the (mPAD) and the PA:Ao diameter ratio - and invasive haemodynamic parameters measured by right heart catheterization,

    1 Day

Study Arms (1)

Precapillary PHTn Proved by RHC

Other: right heart catheter

Interventions

. Right Heart Catheterization : All right heart catheterization procedures will be performed in the Cardiac Catheterization Laboratory at Assiut University Hospital by an accredited cardiologist or chest physician with dedicated PH catheterization experience. The procedure will be conducted in accordance with the 2022 ESC/ERS Guidelines on PH. Equipment * 7-French balloon-tipped thermodilution Swan-Ganz catheter. * Multi-channel pressure transducer system, zeroed at mid-axillary line at the level of the right atrium. * Continuous ECG, SpO₂, and non-invasive blood pressure monitoring throughout. * Fluoroscopy with stored images confirming catheter position at RA, RV, PA, and PAWP RHC Hemodynamic Parameters: Right atrial pressure, Right Ventricular Pressure - systolic (RVSP), Right Ventricular End-Diastolic Pressure (RVEDP), Pulmonary Arterial Pressure - systolic (sPAP), Pulmonary Arterial Pressure - diastolic (dPAP), Mean Pulmonary Arterial Pressure (mPAP), Pulmonary Arterial Wedge Pre

Precapillary PHTn Proved by RHC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults with precapillary PHTN with contraindications to CTPA

You may qualify if:

  • Age ≥ 18 years at time of enrolment. 2-Confirmed pre-capillary pulmonary hypertension on RHC performed at Assiut University Hospital: mPAP \> 20 mmHg AND PAWP ≤ 15 mmHg AND PVR ≥ 2 Wood Units.
  • WHO PH Clinical Group 1 (PAH), Group 3 (PH due to lung disease/hypoxia), or Group 4 (CTEPH / chronic thromboembolic PH) classification assigned by the PH-MDT.

You may not qualify if:

  • WHO PH Group 2 (PH due to left heart disease) or Group 5 (PH with unclear/multifactorial mechanisms) .
  • Active malignancy.
  • Pregnancy, confirmed or suspected.
  • Contraindication to iodinated contrast agent: eGFR \< 30 mL/min/1.73m² OR documented history of severe anaphylactic contrast reaction.
  • Inability to sustain breath-hold of ≥ 8 seconds (impairs CTPA quality).
  • Initiation or dose escalation of pulmonary vasodilator therapy (endothelin receptor antagonist, PDE5 inhibitor, soluble guanylate cyclase stimulator, or prostanoid) in the interval between CTPA and RHC, or within 4 weeks prior to CTPA.
  • Patient refusal to consent or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Hypertension, PulmonaryCataract, posterior polar, 1

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Entsar H Mohamed, dr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 25, 2026

Study Start

June 30, 2026

Primary Completion

June 30, 2026

Study Completion

July 30, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Locations