A Phase 4 interventional study of Sotatercept in Pulmonary Arterial Hypertension, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Other
The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 30 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks.
Drug: Sotatercept
As per FDA indications, sotatercept will be administered as 0.3 mg/kg injection for the first dose followed by 0.7 mg/kg injections for subsequent doses.
Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)
Time frame: Baseline, Week 24
Oxygen Consumption (VO2)
VO2 will be measured in mL/kg/min. It will be directly measured using expired gas analysis.
Time frame: Baseline, 24 weeks
Single leg blood flow at peak exercise
Single leg blood flow will be obtained from venous access. Single leg blood flow will be measured in ml/min
Time frame: Baseline, 24 weeks
Pulmonary vascular resistance at rest
Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Time frame: Baseline, 24 weeks
Pulmonary vascular resistance at peak exercise
Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Time frame: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at rest
PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Time frame: Baseline, 24 weeks
Pulmonary arterial (PA) compliance at peak exercise
PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Time frame: Baseline, 24 weeks
Pulmonary arterial elastance at rest
PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)
Time frame: Baseline, 24 weeks
Pulmonary arterial elastance at peak exercise
PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)
Time frame: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at rest
LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Time frame: Baseline, 24 weeks
Left ventricular (LV) transmural pressure at peak exercise
LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Time frame: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at rest
Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Time frame: Baseline, 24 weeks
Right Ventricular Pulmonary Artery Coupling at peak exercise
Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Time frame: Baseline, 24 weeks
Eccentricity index at rest
Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Time frame: Baseline, 24 weeks
Eccentricity index at peak exercise
Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Time frame: Baseline, 24 weeks
Right atrial pressure (RA) at rest
RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Time frame: Baseline, 24 weeks
Right atrial pressure (RA) at peak exercise
RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Time frame: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise
Dm is measured in ml/mm Hg/min during peak exercise
Time frame: Baseline, 24 weeks
Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise
Dm is measured in ml/mm Hg/min during single leg exercise
Time frame: Baseline, 24 weeks
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension→
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