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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotatercept Therapy | Experimental | All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise | Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min) | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Consumption (VO2) | VO2 will be measured in mL/kg/min. It will be directly measured using expired gas analysis. | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yogesh Reddy, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41885673 | Derived | Reddy YNV, Frantz RP, Miranda WR, Harada T, Kazui S, Borlaug BA. Sotatercept in Pulmonary Arterial Hypertension: Central, Hematologic, and Peripheral Mechanisms of Benefit. J Am Coll Cardiol. 2026 Mar 2:S0735-1097(26)05633-0. doi: 10.1016/j.jacc.2026.02.5103. Online ahead of print. |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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| Baseline, 24 weeks |
| Pulmonary vascular resistance at rest | Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min) | Baseline, 24 weeks |
| Pulmonary vascular resistance at peak exercise | Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min) | 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. | 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. | 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) | 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) | 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 | 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 | 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) | 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) | 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 | 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 | Baseline, 24 weeks |
| Right atrial pressure (RA) at rest | RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks | 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 | 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 | 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 | Baseline, 24 weeks |