- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07707193
Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension (Sch-PAH RV-PA)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed M Sayed, Assistant lecturer
- Número de teléfono: +201095630589
- Correo electrónico: ahmed_mahmoud4@med.sohag.edu.eg
Ubicaciones de estudio
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Al Mansurah, Egipto
- Mansoura University Hospitals
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Contacto:
- Ahmed M Sayed, Assistant lecturer
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Casos
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right heart catheterization for measure pulmonary artery pressure Through swan ganz catheter
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline
Periodo de tiempo: 1 year
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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).
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1 year
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Blanca-Jover E, Contreras-Chova F, Jerez-Calero A, Uberos-Fernandez J, Perez-Lara L. Congenital Heart Disease and Pulmonary Arterial Hypertension: Current Perspectives. Rev Cardiovasc Med. 2026 Mar 20;27(3):48337. doi: 10.31083/RCM48337. eCollection 2026 Mar.
- Lee SY, Jung HO, Kim KA, Oh GC, Jung MH, Youn JC, Chung WB, Youn HJ. Impact of the New Definition on the Prognosis of Patients With Pulmonary Hypertension Compared to the Classic Definition. Korean Circ J. 2025 Nov;55(11):984-997. doi: 10.4070/kcj.2024.0416. Epub 2025 Jul 1.
- Gupfert M, Weber L, Haager PK, Baier P, Kopp S, Rigger J, Chronis J, Gerhard M, Rickli H, Maeder MT. Impact of Right Heart Catheterization and the 2022 ESC/ERS Definition of Pulmonary Hypertension in Patients With Mitral Regurgitation Undergoing Valve Repair/Replacement. Pulm Circ. 2026 Feb 12;16(1):e70265. doi: 10.1002/pul2.70265. eCollection 2026 Jan.
- Soliman YMA, El-Kassas M, ElAziz AA, Mousa MS, Hasswa MK, Magdy S, Elkorashy R. Clinical and hemodynamic evaluation of schistosomiasis-associated pulmonary arterial hypertension from Egyptian pulmonary hypertension centers: epidemiology, risk factors, and survival determinants. Sci Rep. 2026 Mar 21;16(1):9668. doi: 10.1038/s41598-026-41412-7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Sohag-Med--26-6-4 MD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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