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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Pulmonary arterial hypertension Hypertension MedlinePlus related topics: High Blood Pressure Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: Each eligible participant will be randomized in a 1:1 ratio to 1 of the following 2 treatment arms during the double-blind placebo-controlled (DBPC) Treatment Period: Arm 1: Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy Arm 2: Sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, SC every 21 days plus background PAH therapy Show less Masking : Triple ( Participant Care Provider Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment Placebo Comparator : Placebo plus background PAH therapy Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy Other : Placebo Placebo Experimental : Sotatercept plus background PAH therapy Sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg, SC every 21 days plus background PAH therapy Drug : Sotatercept Sotatercept is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1. Other Names: MK-7962 ACE-011 Primary Outcome Measures Outcome Measure Measure Description Time Frame Time to First Confirmed Morbidity or Mortality Event Events are defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. All events will be adjudicated by a blinded, independent committee of clinical experts. Up to approximately 43 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame Overall survival (OS) OS is defined as the time from randomization to death due to any cause. Up to approximately 43 months Transplant-Free Survival Transplant-free survival is defined as the time from randomization to the first lung transplantation or death due to any cause. Up to approximately 43 months Percentage of Participants Who Experienced a Mortality Event Mortality event is defined as death due to any cause throughout the study. Up to approximately 43 months Change From Baseline in REVEAL Lite 2 Risk Score at Week 24 The REVEAL Lite 2 uses renal insufficiency (by estimated glomerular filtration rate (eGFR)), World Health Organization (WHO) functional class (FC), systolic blood pressure (SBP) and heart rate, 6-Minute Walk Distance (6-MWD), and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of ≤5, intermediate risk as a score of 6 or 7, and high risk as a score of ≥8 for the survival rates. Baseline and Week 24 Percentage of Participants Achieving a Low or Intermediate (≤7) REVEAL Lite 2 Risk Score at Week 24 The REVEAL Lite 2 uses renal insufficiency (eGFR), WHO FC, SBP and heart rate, 6-MWD, and NT-proBNP to determine the total risk score. The scores (range: 1-14) can be defined as: low risk as a score of ≤5, intermediate risk as a score of 6 or 7, and high risk as a score of ≥8 for the survival rates. Week 24 Change From Baseline in NT-proBNP levels at Week 24 Blood samples will be collected at baseline and at Week 24 to measure NT-proBNP levels. Baseline and Week 24 Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 24 mPAP was measured by right heart catheterization (RHC) at baseline and at Week 24. mPAP is a hemodynamic parameter used to diagnose PAH. Baseline and Week 24 Change From Baseline in Pulmonary Vascular Resistance (PVR) PVR is a hemodynamic variable measured by RHC at baseline and at Week 24. Baseline and Week 24 Percentage of Participants Who Improve in WHO FC The severity of an individual's PAH symptoms was graded using the WHO FC system. WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC is classified into 'Improved', 'No change' and 'Worsened'. Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. Up to approximately 43 months Change From Baseline in 6-MWD at Week 24 6-MWD is a measure of exercise capacity. Baseline and Week 24 Change From Baseline in Cardiac Output (CO) at Week 24 CO is the volume of blood pumped by the heart per minute. Baseline and Week 24 Change From Baseline in EuroQoL-5 Dimensions Scale 5 Levels (EQ-5D-5L) Index Score at Week 24 EQ-5D-5L measures health outcome. It consists of of descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L system has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into 5 levels of perceived problems (Level 1-no problem, Level 2-slight problems, Level 3-moderate problems, Level 4-severe problems, Level 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health 'today'. Responses will be used to generate an index score.
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