Assiut University Hospital
Asyut, Asyut Governorate, 71515, Egypt
NCT Number: NCT07667595
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Asyut, Asyut Governorate, 71515, Egypt
This is a prospective, cross-sectional , analytical study. All eligible patients referred to the Pulmonary Hypertension Clinic and Catheterisation Laboratory at Assiut University Hospital who undergo both CTPA and RHC as part of standard clinical care will be enrolled consecutively after providing an informed consent.
The hospital maintains a dedicated Pulmonary Hypertension Multidisciplinary Team (MDT) comprising chest physicians, cardiologists, and cardiothoracic radiologists, and performs regular right heart catheterizations.
All CTPA measurements will be performed independently by two trained radiologists (Reader 1 and Reader 2) who are blinded to the RHC hemodynamic results Vascular Measurements : Main PA Diameter (mPAD), Ascending Aorta Diameter Same axial level as mPAD, PA : Ao Ratio (mPAD ÷ Aortic diameter) Calculated value, RV Maximum Transverse Diameter, LV Maximum Transverse Diameter Same axial slice as RV measurement, RV : LV Diameter Ratio (RV ÷ LV), RA diameters, and lung parenchymal affection
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
Parameters: Estimated RVSP, TAPSE (M-mode, apical 4-chamber, lateral tricuspid annulus), RV Fractional Area Change, RV S' - Tissue Doppler, lateral tricuspid annulus peak systolic velocity ,RV Free Wall Longitudinal Strain (GLS, 3-segment or 6-segment), TAPSE / sPAP Ratio , RV and LV dimensions, and RA dimensions.
The following routine laboratory investigations will be performed as part of the study baseline assessment. All samples will be collected on the day of enrolment or within 48 hours.
Parameters: Hemoglobin (Hb), Hematocrit (Hct),White Blood Cell Count (WBC),Platelet Count, MCV, renal and liver function, serology, arterial blood gases and coagulation profile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1-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.
3-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.
4-Both CTPA and RHC performed within a maximum interval of 4 weeks. b. Exclusion criteria:
. 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
Time frame: 1 Day
Contact information is provided by the study sponsor or research team.
Assiut University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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