NCT07453030Not yet recruiting
Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
PROPULSE-Sch: Long-Term Evaluation of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension Using a Propensity Score-Matched Mirror Cohort
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Caio Júlio César dos Santos Fernandes
- NCT number
- NCT07453030
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Mar 2026 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date.
Other
- World Health Organization (WHO) functional class IV at 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Coração InCor, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.