SOTATERCEPT for Pulmonary arterial hypertension|Idiopathic pulmonary arterial hypertension|Heritable pulmonary arterial hypertension

Inclusion criteria

• {"criterion_text":"- Adult patients between 18-70 years of age with a diagnosis of idiopathic or hereditary pulmonary arterial hypertension"}
• {"criterion_text":"- Able to provide signed informed consent"}
• {"criterion_text":"- WHO functional class between II and IV"}
• {"criterion_text":"- Hemodynamic diagnosis of PAH confirmed by right heart catheterization at screening showing an mPAP > 20 mmHg, Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg and a PVR ≥ 4WU (320 dyn.sec.cm-"}
• {"criterion_text":"- Stable background therapy for at least 3 months before the screening period"}
• {"criterion_text":"- NTproBNP > 300 ng/L"}
• {"criterion_text":"- PAH etiology of either idiopathic or heritable PAH"}

Exclusion criteria

• {"criterion_text":"- Pregnancy, breastfeeding, or intention to become pregnant during the study"}
• {"criterion_text":"- Recently started (< 8 weeks prior to informed consent signature) or planned cardio-pulmonary rehabilitation program"}
• {"criterion_text":"- Known concomitant life-threatening disease with a life expectancy < 12 months"}
• {"criterion_text":"- Hospitalization for PAH within 3 months prior to informed consent signature"}
• {"criterion_text":"- Left atrial volume per body surface area ≥ 43mL/m2 by echocardiography or CMR"}
• {"criterion_text":"- History of pulmonary embolism or deep vein thrombosis"}
• {"criterion_text":"- History of major bleeding"}
• {"criterion_text":"- Hemoglobin above upper limit of normal for age and gender"}
• {"criterion_text":"- Atrial fibrillation, multiple premature ventricular or atrial contractions"}
• {"criterion_text":"- Responders to acute vasoreactivity testing based on medical history"}
• {"criterion_text":"- Systolic blood pressure < 90 mmHg"}

Primary endpoints

• {"endpoint_text":"- Change in power per beat after 24 weeks of sotatercept","definition_or_measurement_approach":"Change measured after 24 weeks of sotatercept (timepoint: 24 weeks)."}
• {"endpoint_text":"- Change in right ventricular pulmonary artery coupling index (Ees/Ea) after 24 weeks of sotatercept","definition_or_measurement_approach":"Change in the right ventricular–pulmonary artery coupling index (Ees/Ea) measured after 24 weeks of sotatercept (timepoint: 24 weeks)."}

Secondary endpoints

• {"endpoint_text":"- ∆ Right Ventricular End Diastolic Volume (RVEDV)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Right Ventricular End Systolic Volume (RVESV)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Right Ventricular Ejection Fraction (RVEF)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Right Ventricular mass","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Stroke Volume determined from aortic flow","definition_or_measurement_approach":"Stroke volume measured/determined from aortic flow."}
• {"endpoint_text":"- ∆ Left Ventricular End Diastolic Volume (LVEDV)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Left Ventricular End Systolic Volume (LVESV)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Left Ventricular Ejection Fraction (LVEF)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Left ventricular mass","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ End-systolic elastance (Ees)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Arterial elastance (Ea)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ End diastolic elastance (Eed)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ∆ Extracellular volume as measured by cardiac magnetic resonance imaging","definition_or_measurement_approach":"Extracellular volume measured by cardiac magnetic resonance imaging (cMRI)."}

Netherlands

Earliest CTIS Part Ii Submission Date

07-04-2025

Latest Decision Or Authorization Date

29-01-2026

Processing Time Days

297

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands