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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 183 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | August 20, 2025 |
| Main results expected | August 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07013149 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
- Study coordinator: Caio Fernandes, Principal Investigator
- Email: caio.cesar@hc.fm.usp.br
- Phone: PhD
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.