Trial intelligence / Profile preview

SuMILE Trial: Sotatercept Add-on vs Standard Pulmonary Vasodilator Therapy in Pulmonary Vasodilator-resistant PAH with Unrepaired Congenital Shunts

jRCT1071250069Recruiting

Sponsor
Grants-in-Aid for Scientific Research (C)
Start
Nov 2025
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Countries
1
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Overview

Randomised, open-label trial in pulmonary arterial hypertension (PAH), Eisenmenger syndrome and congenital heart disease-associated pulmonary hypertension (CHD-PAH) comparing Sotatercept add-on plus standard of care with Standard of care alone (2 arms). Started Nov 2025; status: recruiting.

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Drugs

sotatercept
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Conditions

pulmonary arterial hypertension (PAH)Eisenmenger syndromecongenital heart disease-associated pulmonary hypertension (CHD-PAH)

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