NCT07013149 The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
| NCT ID | NCT07013149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 121 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 121 participants in total. It began in 2025-08-20 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pulmonary arterial hypertension (PAH) is a rare, progressive, and potentially fatal disease characterized by increased pulmonary vascular resistance and right ventricular dysfunction. Among the four major molecular pathways involved in PAH pathophysiology-nitric oxide, prostacyclin, activin, and endothelin-1 (ET-1)-the endothelin pathway plays a central role. Endothelin-1 acts on ETA and ETB receptors, inducing vasoconstriction and vascular remodeling. Endothelin receptor antagonists (ERAs) are cornerstone therapies in PAH. Ambrisentan is selective for ETA and associated with a lower risk of hepatotoxicity. Bosentan, a dual ERA (ETA/ETB), has well-established efficacy but a higher incidence of liver enzyme elevation, with approximately 9% of patients experiencing hepatic side effects and about 2% discontinuing therapy due to hepatotoxicity. While transitions between ERAs occur in routine clinical practice, data on their clinical impact are scarce. This prospective, observational, single-center cohort study aims to evaluate the effect of switching from ambrisentan to bosentan on risk stratification using the COMPERA 2.0 and REVEAL Lite 2.0 scores at 3-6 months post-switch. Secondary outcomes include variations in functional class (WHO/NYHA), 6-minute walk distance (6MWD), NT-proBNP levels, incidence of adverse events (with a focus on hepatotoxicity), and hematologic parameters such as anemia. The study will enroll adult patients (≥18 years) with confirmed PAH by right heart catheterization who have undergone a documented switch from ambrisentan 10 mg to bosentan 125 mg within the last 6 months. The primary endpoint is the proportion of patients whose risk category changes post-transition according to COMPERA 2.0 and REVEAL Lite 2.0. The results are expected to provide clinically relevant insights into therapeutic decisions involving ERA transitions in PAH management.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07013149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07013149 currently recruiting?
Yes, NCT07013149 is actively recruiting participants. Contact the research team at caio.cesar@hc.fm.usp.br for enrollment information.
Where is the NCT07013149 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07013149 clinical trial?
NCT07013149 is sponsored by University of Sao Paulo General Hospital. The trial plans to enroll 121 participants.