Switching endothelin receptor medicines and risk in pulmonary arterial hypertension
ACTION - The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
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 |
|---|---|
| Enrollment | 121 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07013149 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.