An observational study in Pulmonary Arterial Hypertension (PAH), sponsored by Caio Júlio César dos Santos Fernandes. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Caio Júlio César dos Santos Fernandes · Observational
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.
Schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) is a prevalent cause of pulmonary arterial hypertension in endemic regions and is associated with significant morbidity and premature mortality. Despite advances in targeted therapies for pulmonary arterial hypertension, patients with PAH-Sch remain underrepresented in long-term studies, particularly in real-world clinical settings.
Selexipag, an oral selective prostacyclin IP receptor agonist, has demonstrated clinical and hemodynamic benefits in pulmonary arterial hypertension. Following its incorporation into routine clinical practice in Brazil, selexipag has been increasingly used in eligible patients with PAH-Sch. However, evidence regarding its long-term outcomes in this specific population is limited.
PROPULSE-Sch is a single-center, observational, longitudinal study with an ambispective design, combining retrospective data and prospective follow-up. The study evaluates long-term clinical outcomes associated with exposure to selexipag in patients with PAH-Sch, compared with a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. To reduce confounding and indication bias inherent to observational comparisons, analyses are conducted using propensity score matching.
All treatment decisions, including initiation and intensification of therapy, are made exclusively by the treating physicians as part of routine clinical care. The study does not mandate any intervention, treatment assignment, or protocol-driven management. Data are obtained from medical records and standard follow-up visits. By using real-world data and robust observational methods, this study aims to contribute clinically relevant evidence on long-term outcomes in schistosomiasis-associated pulmonary arterial hypertension.
The study population includes adult patients with schistosomiasis-associated pulmonary arterial hypertension (PAH-Sch) followed at a specialized pulmonary hypertension referral center. The population comprises two observational cohorts: patients who initiated oral selexipag as part of routine clinical care and a mirror cohort of clinically similar patients who did not receive selexipag prior to its availability at the center. All patients have confirmed pre-capillary pulmonary arterial hypertension and stable background therapy at the index date. Participants are followed longitudinally using data obtained from routine clinical practice to assess long-term clinical outcomes. No study-mandated interventions are performed.
Adults aged 18 years or older.
Exclusion Criteria
Adult patients with schistosomiasis-associated pulmonary arterial hypertension who initiated oral selexipag as part of routine clinical care. The index date (T0) is defined as the date of selexipag initiation recorded in the medical record. Patients are followed longitudinally to assess long-term clinical outcomes.
Adult patients with schistosomiasis-associated pulmonary arterial hypertension who did not receive selexipag and were followed at the same center prior to its availability. The index date (T0 mirror) is defined as the first visit at which patients met clinical eligibility criteria comparable to those of the treated cohort.
Time to Clinical Worsening
Time from the index date (T0) to the first occurrence of clinical worsening, defined as any of the following events: all-cause mortality; lung transplantation; non-elective hospitalization due to pulmonary arterial hypertension or right heart failure; therapeutic escalation defined as initiation of parenteral prostacyclin or addition of a new class of pulmonary arterial hypertension-specific therapy; or sustained worsening of World Health Organization functional class confirmed in two consecutive assessments at least 12 weeks apart and accompanied by objective evidence of disease progression, including a ≥15% decrease in six-minute walk distance and/or a ≥30% increase in BNP or NT-proBNP compared with baseline.
Time frame: From index date (T0) up to 36 months of follow-up
Clinical Improvement Composite Outcome
Composite clinical improvement defined as improvement in at least two of the following criteria compared with baseline, without occurrence of clinical worsening: increase of at least 10% or 30 meters in six-minute walk distance; improvement to World Health Organization functional class I or II; or reduction of at least 30% in BNP or NT-proBNP levels.
Time frame: 6, 12, 24, and 36 months after index date
Change in WHO Functional Class
Change in WHO Functional Class
Time frame: Up to 36 months of follow-up
Change in 6-Minute Walk Distance (6MWD)
Change in 6-Minute Walk Distance (6MWD)
Time frame: Up to 36 months
Change in BNP or NT-proBNP Levels
Change in BNP or NT-proBNP Levels
Time frame: Up to 36 months
Hemodynamic Parameters
Change in Mean Pulmonary Arterial Pressure (mPAP)
Time frame: Up to 36 months of follow-up
Risk Stratification Scores
Changes in pulmonary arterial hypertension risk stratification assessed using the COMPERA 2.0 risk score (four risk strata: low, intermediate-low, intermediate-high, and high risk), evaluated during follow-up when sufficient clinical, functional, and laboratory data are available.
Time frame: Up to 36 months of follow-up
Treatment Tolerability
Occurrence of adverse events during follow-up.
Time frame: Up to 36 months of follow-up
Hemodynamic Parameters
Change in Pulmonary Vascular Resistance (PVR)
Time frame: Up to 36 months
Hemodynamic Parameters
Change in Pulmonary Capillary Wedge Pressure (PCWP)
Time frame: Up to 36 months
Hemodynamic Parameters
Change in Cardiac Output or Cardiac Index
Time frame: Up to 36 months
Plan to share: No
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Pulmonary Arterial Hypertension→
Caio Júlio César dos Santos Fernandes