Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline
研究概览
简要总结
Pulmonary Arterial Hypertension is a progressive and potentially fatal cardiopulmonary disorder characterized by remodeling of the pulmonary vasculature, progressive elevation of pulmonary vascular resistance (PVR), and eventual right ventricular (RV) failure.
According to the 2022 European Society of Cardiology/European Respiratory Society (ESC/ERS) guidelines, pulmonary hypertension is currently defined hemodynamically by a mean pulmonary arterial pressure (mPAP) >20 mmHg measured by right heart catheterization, while pulmonary arterial hypertension is additionally characterized by pulmonary arterial wedge pressure (PAWP) ≤15 mmHg and PVR >2 Wood units.
Schistosomiasis-associated pulmonary arterial hypertension (Sch-PAH) is classified within Group 1 PAH and represents one of the most important causes of PAH in endemic regions, particularly in developing countries such as Egypt and Brazil.
Schistosomiasis is considered the second most prevalent parasitic disease worldwide after malaria, affecting more than 200 million individuals globally. Chronic hepatosplenic schistosomiasis may lead to porto-systemic shunting, allowing parasite eggs to embolize into the pulmonary circulation, triggering chronic inflammation, endothelial dysfunction, and pulmonary vascular remodeling.
The pathological changes observed in Sch-PAH resemble those seen in idiopathic PAH, including medial hypertrophy, intimal fibrosis, and plexiform lesions. However, several studies suggest that patients with Sch-PAH may exhibit better long-term survival compared with idiopathic PAH despite comparable pulmonary hemodynamic impairment.
The mechanisms underlying this relatively favorable prognosis remain incompletely understood.
Right ventricular adaptation to increased afterload is currently recognized as one of the principal determinants of prognosis in PAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients above 18 year diagnosed with schistozomiasis through history of exposure , serology , positive stool antigens ,Symmers' periportal fibrosis (the "clay pipe-stem" appearance) or Splenomegaly and suspected pulmonary hypertension through Probability Score" approach based on the 2022 ESC/ERS
排除标准
- •All patients below 18 years old.
- •Left ventricular systolic or diastolic dysfunction.
- •Significant left-sided valvular heart disease.
- •severe chronic lung disease such as, Chronic obstructive pulmonary disease (COPD) ---- GOLD 4 and severe Interstitial lung disease (ILD).
- •Chronic Thromboembolic Pulmonary Hypertension.
- •Congenital heart diseases.
- •Severe hepatic or renal impairment unrelated to schistosomiasis.
- •Hemodynamically unstable patients.
- •Poor echocardiographic window preventing adequate RV assessment.
- •Active infection or acute systemic illness.
- •Refusal to participate in the study.
- •Significant arrhythmias affecting hemodynamic assessment (e.g., uncontrolled atrial fibrillation).
- •Previous heart or lung transplantation.
- •Pregnancy.
结局指标
主要结局
Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline
时间窗: 1 year
The tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio will be measured by standard transthoracic echocardiography in all participants at the study assessment. TAPSE will be measured in millimeters (mm) using M-mode echocardiography, and PASP will be estimated in mmHg from the peak tricuspid regurgitation velocity. The TAPSE/PASP ratio (mm/mmHg) will be calculated for each participant and reported as a continuous variable (mean ± standard deviation or median \[interquartile range\], depending on data distribution).
次要结局
未报告次要终点
研究者
Ahmed Mohamed Sayed
Assistant lecturer in Chest Department Faculty of Medicine ,Sohag University
Sohag University