Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension

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Conditions studied: Pulmonary Arterial Hypertension (PAH)

In brief

Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Although treatments for pulmonary arterial hypertension have improved over time, patients with this specific cause of the disease are often not included in long-term studies. Selexipag is an oral medication used to treat pulmonary arterial hypertension and is part of routine clinical care in Brazil. Its long-term effects in patients with schistosomiasis-associated pulmonary arterial hypertension are not well understood. The PROPULSE-Sch study aims to evaluate long-term clinical outcomes in patients with schistosomiasis-associated pulmonary arterial hypertension who received selexipag, compared with similar patients who did not receive this medication before it became available at the study center. This is an observational study using data from routine medical care. All treatments are prescribed by the treating physicians, and participation in the study does not change patient care. The results may help improve understanding of long-term outcomes and support treatment decisions in this population.

Key facts

Study ID

NCT07453030

Run by

Caio Júlio César dos Santos Fernandes

People needed

30

Starts

2026-03-01

Expected to finish

2027-03-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older.
• Confirmed diagnosis of pulmonary arterial hypertension associated with schistosomiasis (PAH-Sch).
• Diagnosis of pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization, performed at any time prior to the index date (T0), as documented in the medical record.
• Evidence of schistosomiasis infection, including epidemiological history and ultrasonographic findings compatible with hepatosplenic schistosomiasis.
• Previous antiparasitic treatment for schistosomiasis.
• Clinical stability at the index date, defined as absence of progressive right heart failure or clinical worsening within the previous 12 weeks.
• World Health Organization (WHO) functional class I-III at the index date.
• Stable background pulmonary arterial hypertension-specific therapy with a phosphodiesterase-5 inhibitor and/or endothelin receptor antagonist for at least 12 weeks prior to the index date.
• For the treated cohort: initiation of oral selexipag as part of routine clinical care.
• For the mirror cohort: eligibility for therapeutic escalation at the index date without exposure to selexipag.

You may not qualify if…

• World Health Organization (WHO) functional class IV at the index date.
• Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date.
• Documented formal contraindication to selexipag in the medical record.
• Insufficient baseline data at the index date to allow clinical characterization or inclusion in propensity score analyses.

Where it is running

• Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo — São Paulo, São Paulo, Brazil

Full record on ClinicalTrials.gov

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