Clinical trial Recruiting at 1 site Observational Ages 18 and up

Switching endothelin receptor medicines and risk in pulmonary arterial hypertension

Official title: ACTION - The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension

Run by University of Sao Paulo General Hospital · NCT07013149 · Data updated 2026-11-12

This study will try switching adults with PAH from ambrisentan to bosentan to see if the change alters their clinical risk profile and liver safety.

More Pulmonary Arterial Hypertension trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment183 (estimated)
SponsorUniversity of Sao Paulo General Hospital
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedAugust 20, 2025
Main results expectedAugust 1, 2026
Study endsDecember 1, 2026
Registry record updatedJuly 6, 2026
Trial IDNCT07013149 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with PAH confirmed by right heart catheterization who have switched from ambrisentan to bosentan within the previous six months and can attend follow-up visits.

Probably not a fit

Patients with severe hepatic impairment, incomplete medical records, or inability to attend the required 3–6 month follow-up are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational cohort of adults with right-heart-catheterization–confirmed PAH who have changed therapy from ambrisentan to bosentan within the prior six months. Researchers will collect clinical data, risk scores, laboratory tests (including liver enzymes), and follow-up assessments between 3 and 6 months after the switch. The goal is to describe real-world effects of the medication change on risk stratification, functional status, and hepatic safety. Data are recorded at a single center (InCor - FMUSP, University of São Paulo) using routine clinical visits and chart review.

Why it matters

Potential benefit: If successful, the results could help doctors decide whether switching from ambrisentan to bosentan is safe and whether it changes patients' clinical risk or monitoring needs.

How similar studies have gone: Limited retrospective series (e.g., Gong et al. 2022) have suggested no major adverse hemodynamic or functional effects after switching, but prospective data are scarce.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed diagnosis of pulmonary arterial hypertension (PAH) by right heart catheterization
* Documented therapeutic switch from ambrisentan (10 mg once daily) to bosentan (125 mg twice daily) within the previous 6 months for the switch group
* Treatment with ambrisentan for at least 6 months without switching to bosentan for the maintenance group

Exclusion Criteria:

* History of severe hepatic impairment
* Incomplete clinical or laboratory records that prevent risk score calculation
* Inability to attend clinical follow-up between 3 and 6 months after medication switch

Where it's running

  • InCor - FMUSP
    São Paulo, São Paulo, Brazil
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.