Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
- Registration Number
- NCT06409026
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sotatercept Therapy Sotatercept All participants will receive 36 weeks of sotatercept therapy. Sotatercept is administered as a subcutaneous injection once every 3 weeks.
- Primary Outcome Measures
Name Time Method Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise Baseline, Week 24 Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)
- Secondary Outcome Measures
Name Time Method Oxygen Consumption (VO2) Baseline, 24 weeks VO2 will be measured in mL/kg/min. It will be directly measured using expired gas analysis.
Pulmonary vascular resistance at peak exercise Baseline, 24 weeks Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Pulmonary arterial (PA) compliance at peak exercise Baseline, 24 weeks PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Pulmonary arterial elastance at rest Baseline, 24 weeks 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)
Pulmonary arterial elastance at peak exercise Baseline, 24 weeks 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)
Pulmonary arterial (PA) compliance at rest Baseline, 24 weeks PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.
Left ventricular (LV) transmural pressure at peak exercise Baseline, 24 weeks LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Single leg blood flow at peak exercise Baseline, 24 weeks Single leg blood flow will be obtained from venous access. Single leg blood flow will be measured in ml/min
Pulmonary vascular resistance at rest Baseline, 24 weeks Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)
Right Ventricular Pulmonary Artery Coupling at rest Baseline, 24 weeks Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Right Ventricular Pulmonary Artery Coupling at peak exercise Baseline, 24 weeks Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)
Right atrial pressure (RA) at rest Baseline, 24 weeks RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Right atrial pressure (RA) at peak exercise Baseline, 24 weeks RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks
Eccentricity index at peak exercise Baseline, 24 weeks Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise Baseline, 24 weeks Dm is measured in ml/mm Hg/min during single leg exercise
Left ventricular (LV) transmural pressure at rest Baseline, 24 weeks LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure
Eccentricity index at rest Baseline, 24 weeks Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram
Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise Baseline, 24 weeks Dm is measured in ml/mm Hg/min during peak exercise
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States