NCT07498803

Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome

Sota-ES - A Prospective, Non-randomized, Open-label, Multi-center Study of the Activin Signaling Inhibitor Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Philipps University Marburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present study seeks to provide pilot data on the safety and efficacy of medical therapy with sotatercept in patients with an established diagnosis of congenital heart disease and Eisenmenger syndrome. CHASE is an interventional, single-arm, open-label study, that will enroll 40 patients with an established diagnosis of CHD and Eisenmenger syndrome. PAH background therapy may be present at the discretion of the investigators at the time of enrolment. CHASE will be performed only in countries where standard PAH therapies are available and reimbursed. At the end of the 24-week patient period, PAH treatment is left to the investigator's discretion.

Conditions

• Congenital Heart Disease (CHD)
• Eisenmenger Syndrome
• PAH

Interventions

Type	Name	Description
DRUG	Sotatercept	Sotatercept will be administered subcutaneously in 3-weekly intervals at study sites beginning at a dose of 0.3 mg/kg body weight followed by up titration to the target dose of 0.7 mg/kg body weight.

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-03-31
• Completion: 2028-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27