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Clinical trial

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

NCT07356778 is registered in ClinicalTrials.gov with Kazuya Hosokawa as lead sponsor.

NCT NCT07356778
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Kazuya Hosokawa
Phase
Phase 4
Overall status
Recruiting
Start date
October 7, 2025
Completion date
April 30, 2028
Enrollment
36 (estimated)
Sites
10

Conditions

As the registry lists them; a condition with its own page is linked.

eisenmenger syndrome, pulmonary arterial hypertension of congenital heart disease