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Not Yet RecruitingNCT07052968

Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
75 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

Patients with CKD who suspected to have pulmonary hypertension by echocardiography with high probability, RHC used to confirm the diagnosis, assessment of hemodynamic parameters, differentiate pre and post capillary types of pulmonary hypertension and asses severity of the disease.

Detailed description

Pulmonary Hypertension (PH ) is a haemodynamic and pathophysiological condition characterized by an increase in mean pulmonary arterial pressure ≥ 20 mmHg at rest, measured by right heart catheterization \[1\]. It results from various etiologies and multifactorial mechanisms. PH is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) . CKD is defined as abnormalities in kidney structure or function persisting for more than three months, with implications for health. The latest KDIGO guidelines classify CKD based on glomerular filtration rate and albuminuria categories \[2\]. CKD has systemic complications a cardiovascular and pulmonary vascular disorders. The PH in CKD patients is multifactorial, involving volume overload, endothelial dysfunction, vascular calcification, and increased left sided pressures \[3\]. Echocardiography is the primary non-invasive tool for assessing PH . It estimates systolic pulmonary artery pressure and evaluates right ventricular structure and function . Although widely accessible, ECHO has limitations ;operator dependency and potential underestimation or overestimation of pressures \[4\]. ESC/ERS guidelines for pulmonary hypertension in assessing the probablity (6) as : High probability: TRV \>3.4 m/s or TRV 2.9-3.4 m/s with other echo PH signs Intermediate probability: TRV 2.9-3.4 m/s without other echo PH signs Low probability: TRV ≤2.8 m/s and no other PH signs. Right heart catheterization (RHC) remains the gold standard for definitive PH diagnosis. It provides direct hemodynamic measurements, distinguishing pre-capillary from post-capillary PH. RHC is crucial for guiding targeted therapy and risk stratification, ensuring accurate management in CKD patients with suspected PH (5).

Conditions

Interventions

TypeNameDescription
DEVICEEchocardiographyEchocardiography is the non invasvive interventional assessment and the RHC is the invasive international assessment of the hemodynamics in PH patients with ckd.

Timeline

Start date
2025-08-01
Primary completion
2026-06-01
Completion
2026-07-01
First posted
2025-07-08
Last updated
2025-07-08

Source: ClinicalTrials.gov record NCT07052968. Inclusion in this directory is not an endorsement.

Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient (NCT07052968) · Clinical Trials Directory