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Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atrial septal defect, ventricular septal defect or patent ductus arteriosus), including Eisenmenger syndrome: the SuMILE trial

bmjopen · abstract · 2026-03-12 · 1 matching annotations

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vasodilator-based PAH therapy Sotatercept Eisenmenger syndrome pulmonary arterial hypertension (PAH)atrial septal defect ventricular septal defect

…rome, will be randomised 2:1 to sotatercept add-on therapy plus vasodilator-based PAH therapy versus vasodilator-based PAH therapy alone. Sotatercept will be…

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vasodilator-based PAH therapy

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