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临床试验/NCT07052968
NCT07052968尚未招募不适用

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

Assiut University0 个研究点目标入组 75 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
主要终点
Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • • 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.

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randa Ahmed Sarhan

Dr,

Assiut University

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