Phase 3 Pulmonary Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with pulmonary arterial hypertension (a type of high blood pressure in the lungs) confirmed by a heart procedure called a right heart catheterization, and your diagnosis falls into one of these specific types: idiopathic (unknown cause), hereditary, caused by a drug or toxin, related to a connective tissue disease, or related to a repaired heart defect (repaired at least 1 year ago)
• Your symptoms are classified as moderate — meaning you have some limitations during physical activity but are comfortable at rest (confirm with trial site)
• A recent heart catheterization during the screening period shows your blood pressure measurements in the lungs meet specific levels required by the trial (confirm with trial site)
• You have been on a stable treatment plan for pulmonary arterial hypertension for more than 90 days and are willing to continue it throughout the trial
• Your doctor has determined that starting the study drug (Sotatercept) is appropriate for you
• You are willing and able to take part in a home exercise program monitored remotely for 24 weeks
• You are able to attend study visits and follow all study requirements
• You are able to understand and sign a written consent form

Who may not be able to join:

• You have a different type of pulmonary hypertension (not Group 1), such as that caused by left heart disease, lung disease, blood clots, or other unclear causes
• Your pulmonary arterial hypertension is linked to HIV, liver disease (portal hypertension), a parasitic infection called schistosomiasis, or a specific lung vein condition called pulmonary veno-occlusive disease
• Your red blood cell levels (hemoglobin) are above the normal range for your gender at screening
• Your platelet count (cells that help blood clot) is very low at screening
• Your blood pressure is too high (above 160/100 mmHg) or too low (below 90 mmHg systolic) at screening
• You are currently pregnant or breastfeeding
• Your liver or kidney function blood tests are outside the normal range
• You are currently in another clinical trial or have recently completed one involving an experimental drug
• You have previously been treated with Sotatercept or Luspatercept, or have had an allergic reaction to either
• You have had a full surgical removal of one lung
• You have started a structured exercise program within the past 90 days or plan to start one during the study
• You have a known history of portal hypertension or chronic liver disease, including active hepatitis B or C
• You have certain heart-related conditions, including: a history of certain types of heart muscle disease; a heart procedure called atrial septostomy within the past 6 months; an abnormal heart rhythm reading on an ECG; a personal or family history of a heart condition called Long QT Syndrome or sudden cardiac death; reduced heart pumping function (below 45%) on a recent echocardiogram; or a heart attack, heart surgery, or chest pain from coronary disease within the past 6 months
• You have had a stroke within the past 3 months
• You have had a severe episode of heart failure within the past 14 days
• You have significant leaking of certain heart valves (mitral or aortic)
• You have received strong IV heart medications (such as dobutamine or dopamine) within the past 30 days

Important: Always verify eligibility with the trial site directly before applying.