Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCaio Júlio César dos Santos Fernandes
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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 2 trial groupsGroup A: Selexipag-Treated PAH-Sch Cohort
Group B: Mirror PAH-Sch Cohort Without Selexipag
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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 date2
Change in WHO Functional Class
Change in WHO Functional Class
Time frame
Up to 36 months of follow-up3
Change in 6-Minute Walk Distance (6MWD)
Change in 6-Minute Walk Distance (6MWD)
Time frame
Up to 36 months4
Change in BNP or NT-proBNP Levels
Change in BNP or NT-proBNP Levels
Time frame
Up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Caio Júlio César dos Santos Fernandes
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
Source ClinicalTrials.gov
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