SchistosomiasisSch-PAH RV-PANCT07707193
Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
A study testing right heart catheterization for measure pulmonary artery pressure in people with Schistosomiasis, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- right heart catheterization for measure pulmonary artery pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura university hospitals
Al Mansurah
Ahmed M Sayed, Assistant lecturer
About this study
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.
Read more
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
- Being tested
- right heart catheterization for measure pulmonary artery pressure
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right heart catheterization for measure pulmonary artery pressureProcedure or surgery
right heart catheterization for measure pulmonary artery pressure Through swan ganz catheter
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Not described Receives: Procedure: right heart catheterization for measure pulmonary artery pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Sayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707193
- Sponsor's protocol ID
- Sohag-Med--26-6-4 MD
- Acronym
- Sch-PAH RV-PA
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41923748Lee 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.
PubMed 40736381Gupfert 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.
PubMed 41695275Soliman 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.
PubMed 41865030
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Right Ventricular-Pulmonary Arterial Coupling in Schistosomiasis-Associated Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07707193
- Acronym / sponsor ID
- Sch-PAH RV-PA / Sohag-Med--26-6-4 MD
- Conditions
- Schistosomiasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Procedure: right heart catheterization for measure pulmonary artery pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| right heart catheterization for measure pulmonary artery pressureright heart catheterization for measure pulmonary artery pressure Through swan ganz catheter | Procedure or surgery | Cases |
Primary outcome
Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 41923748Blanca-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.
- Background: PubMed 40736381Lee 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.
- Background: PubMed 41695275Gupfert 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.
- Background: PubMed 41865030Soliman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing right heart catheterization for measure pulmonary artery pressure in people with Schistosomiasis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Sayed, Assistant lecturer (+201095630589, ahmed_mahmoud4@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular-pulmonary arterial coupling quantified by the TAPSE/PASP ratio measured by transthoracic echocardiography at baseline (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07707193, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.