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

NCT ID: NCT07052968

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-07-31

Brief 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

Pulmonary Hypertension; Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Echocardiography

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Randa Ahmed Sarhan

Dr,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Randa Ahmed, MD

Role: CONTACT

randasarhan@aun.edu.eg

+201118683728

Alaa Omar, Phd

Role: CONTACT

alaa_omar11@yahoo.com

+20102 365 8355

References

Jankowich M, Hebel R, Jantz J, Abbasi S, Choudhary G. Multispecialty pulmonary hypertension clinic in the VA. Pulm Circ. 2017 Oct-Dec;7(4):758-767. doi: 10.1177/2045893217726063. Epub 2017 Aug 22.

Reference Type: BACKGROUND

PMID: 28770656 (View on PubMed)

Pugh ME, Hemnes AR, Trammell A, Newman JH, Robbins IM. Variability in hemodynamic evaluation of pulmonary hypertension at large referral centers. Pulm Circ. 2014 Dec;4(4):679-84. doi: 10.1086/678514.

Reference Type: BACKGROUND

PMID: 25610603 (View on PubMed)

Other Identifiers

RHC in PH pts e ckd

Identifier Type: -

Identifier Source: org_study_id