About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Caio Júlio César dos Santos Fernandes
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution