Sota-ES - Sotatercept in Patients With Congenital Heart Disease and Eisenmenger´s Syndrome
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilipps University Marburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Congenital heart disease with Eisenmenger syndrome (known unrepaired atrial septal defect, and/or ventricular septal defect, and/or patent ductus arteriosus; patients with anomalous pulmonary venous drainage will not be considered)
Eisenmenger syndrome defined as right-to-left or bi-directional shunt with a mPAP >25 mmHg, PAWP < 15 mmHg, and PVR >5 WU
In patients with pre-tricuspid shunt, the consideration of Eisenmenger syndrome requires one of the following: Systemic arterial O2 saturation (SaO2) at rest <88% and more than 70%, and/or SaO2 <80% during 6MWT, and secondary erythrocytosis (Hb > 15.0 g/dl for females and 16.0 g/dl for males)
Disqualifiers
Age <18 years
Diagnosis of pulmonary hypertension groups 2, 3, 4, or 5
Hospitalization or change in PAH background therapies within 30 days prior to screening (changes in dose of diuretics or parenteral prostanoids [<10% change in infusion rate over the preceding 3 months] are allowed)
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mmHg or sitting diastolic blood pressure >100 mmHg during screening visit after a period of rest
Trial design
Design model
Single group
Treatments tested in this trial
Sotatercept
DrugSotatercept 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of the effect on pulmonary vascular resistance (PVR)
Change in PVR from screening at week 24 after 24 weeks of treatment with Sotatercept
Time frame
24weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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