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NCT Number: NCT07052968

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult (aged 18 years old and older) patients who were diagnosed CKD(The presence of kidney damage or an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m², persisting for 3 months or more) and suspected to have pulmonary hypertension by clinical feature or by echocardiography with high probability were included in this study.

Exclusion criteria

  • • Patients under 18 years old
  • Patient with chronic chest disease.
  • Patient bleeding diathesis and high risk of bleeding.
  • Individuals having acute kidney injury.
  • Patient developing other PH aetiologies.

Treatment and study plan

Echocardiography

Device

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

Primary outcomes

  1. Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management.

    Time frame: One year

    Hemodynamic assessment by echo including (right atrial surface area, right ventricular diameters, tricuspid annular plane systolic excursion ,tricusped regureg Jet velocity, inferior vena cava diameter and inspiratory collapability, estimated pulmonary artery pressure and left ventricular structure and function) and Hemodynamic assessment by RHC to diagnose and identify tyoe of PH according theses parameters a mean pulmonary arterial pressure (mPAP) >20 mm Hg, pulmonary artery wedge pressure (PAWP) ≤15mmHg and a PVR > 2WU. Pre-capillary PH ,mPAP >20 mmHg,PAWP ≤15mmHg,PVR ≥3WU.Isolated post-capillary PH (IpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR <3WU. Combined pre- and post-capillary PH (CpcPH),mPAP >20 mmHg,PAWP >15mmHg,PVR ≥3WU.Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test, correlations and regression tests, paired t-test will be

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa Omar, Phd

CONTACT

[email protected]

+20102 365 8355

Randa Ahmed, MD

CONTACT

[email protected]

+201118683728

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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