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New study eyes selexipag for neglected form of lung hypertension

NCT ID NCT07453030

Disease control Sponsor: Caio Júlio César dos Santos Fernandes Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well the oral medication selexipag works over the long term for people with a specific type of lung hypertension caused by schistosomiasis (a parasitic infection). Researchers will compare patients who received selexipag as part of routine care to similar patients who did not get the drug before it was available. The goal is to see if selexipag helps delay worsening of the disease, such as hospitalizations or need for stronger treatments. About 30 adults will be included, and no extra treatments or tests are given—just analysis of existing medical records.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 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. Exclusion Criteria * 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.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension schistosomiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension (PAH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    São Paulo, São Paulo, 05403-900, Brazil

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