Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension

NCT07707193 | Not Yet Recruiting

• 1 other identifier: Sohag-Med--26-6-4 MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schistosomiasis

Outcome Measures

Primary Outcomes (1)

• Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline

  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).

  1 year

Study Arms (1)

Cases

EXPERIMENTAL

Procedure: right heart catheterization for measure pulmonary artery pressure

Interventions

right heart catheterization for measure pulmonary artery pressure PROCEDURE

right heart catheterization for measure pulmonary artery pressure Through swan ganz catheter

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Mansoura university hospitals

Al Mansurah, Egypt

Location

Related Publications (4)

• 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.

  PMID: 41923748 BACKGROUND

• 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.

  PMID: 40736381 BACKGROUND

• 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.

  PMID: 41695275 BACKGROUND

• 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.

  PMID: 41865030 BACKGROUND

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Central Study Contacts

Ahmed M Sayed, Assistant lecturer

CONTACT

+201095630589; ahmed_mahmoud4@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in Chest Department Faculty of Medicine ,Sohag University

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

EG (1)