SuMILE Trial
The trial hypothesis is that sotatercept will improve 6-minute walk distance at 24 weeks. The SuMILE trial evaluates sotatercept add-on therapy against vasodilator-based standard care alone in adults with PAH due to unrepaired ASD, VSD, or…
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The trial hypothesis is that sotatercept will improve 6-minute walk distance at 24 weeks. The SuMILE trial evaluates sotatercept add-on therapy against vasodilator-based standard care alone in adults with PAH due to unrepaired ASD, VSD, or PDA. The trial protocol also seeks to characterise safety, feasibility, blood count dynamics, dose exposure, adverse events, and conditions for safe use.