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

NCT07498803 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Philipps University Marburg

    lead OTHER

Principal Investigators

  • Stephan Rosenkranz, Prof. Dr. · University Hospital Cologne Department of Cardiology, Pulmonology, and Intensive Care Medicine Heart Center Cologne Cardiovascular Research Center (CCRC) Center for Molecular Medicine Cologne (CMMC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-03-31
Completion
2028-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498803 on ClinicalTrials.gov