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The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension

Recruitingn/aAges 18 Years - anyAllUniversity of Sao Paulo General Hospital
NCT07013149 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pulmonary arterial hypertension (PAH) is a rare, progressive, and potentially life-threatening disease characterized by pulmonary vascular remodeling, increased pulmonary vascular resistance, and right ventricular dysfunction. The endothelin pathway plays a central role in its pathophysiology and is targeted by endothelin receptor antagonists (ERAs), including ambrisentan and bosentan. Ambrisentan is a selective ETA receptor antagonist, whereas bosentan blocks both ETA and ETB receptors. Although transitions between ERAs occur in clinical practice, evidence regarding the clinical impact of switching from ambrisentan to bosentan remains limited. ACTION is a retrospective, observational, single-center cohort study evaluating adult patients with pulmonary arterial hypertension (World Health Organization Group 1) and/or chronic thromboembolic pulmonary hypertension (World Health Organizati

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📋 Eligibility rules (as published)
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
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What it tests

  • Switch from Ambrisentan to Bosentan
  • Maintenance of Ambrisentan Therapy
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Where

1 site
InCor - FMUSP
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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