Trial Profile

An Open-label, Randomized, Controlled Trial to Evaluate the Efficacy of Sotatercept Add-on Therapy Compared to Standard PAH Therapy With Pulmonary Vasodilators for Pulmonary Arterial Hypertension Associated With Pulmonary Vasodilator-resistant, Unrepaired Congenital Shunts (ASD, VSD, PDA) Including Eisenmenger Syndrome SuMILE Trial

Status: Recruiting

Phase of Trial: Phase IV

Latest Information Update: 02 Feb 2026

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At a glance

Drugs Sotatercept (Primary) ; Endothelin receptor antagonists; Epoprostenol; Riociguat; Type 5 cyclic nucleotide phosphodiesterase inhibitors
Indications Pulmonary arterial hypertension
Focus Therapeutic Use
Acronyms SuMILE

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