Phase 4 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:

• People aged between 18 and 70 years old
• People who are able to read, understand, and sign a consent form agreeing to take part
• People whose pulmonary arterial hypertension (a type of high blood pressure in the lungs) affects their daily life at a moderate to severe level (known as WHO Functional Class II to IV — confirm with trial site for clarification)
• People with a blood marker called NTproBNP measured above 300 ng/L, which indicates strain on the heart
• People whose PAH has no known cause (idiopathic PAH) or is linked to a genetic/family history (heritable PAH)
• People whose PAH has been confirmed by a right heart catheterisation (a procedure that measures pressure inside the heart and lungs) showing specific pressure and resistance readings within the required ranges
• People taking water tablets (diuretics) by mouth whose dose has been unchanged for at least 1 month before their heart catheterisation test during screening
• People who have been on a stable PAH treatment plan for at least 3 months before their heart catheterisation test during screening
• Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use reliable contraception throughout
• Men must agree to use a condom during sexual contact with a pregnant woman or a woman who could become pregnant while in the study, and must not donate blood or sperm during the study and for 16 weeks after the last dose of the study drug

Who may not be able to join:

• People for whom the study drug sotatercept is medically unsuitable or contraindicated
• People who weigh less than 40 kg
• People with a body mass index (BMI) above 35 kg/m²
• People who are pregnant, breastfeeding, or planning to become pregnant during the study
• People who have recently started (within the last 8 weeks) or are planning to start a heart or lung rehabilitation program
• People with another serious life-threatening illness where life expectancy is less than 12 months
• People with any condition that is likely to make it difficult to follow the study procedures or treatment plan
• People who have been hospitalised due to PAH within the 3 months before signing the consent form
• People whose left side of the heart shows a specific enlargement detected on imaging (confirm with trial site for the exact measurement threshold)
• People with moderate or severe heart valve problems (grade 2 or higher)
• People with a history of blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis)
• People with a confirmed diagnosis of moderate to severe chronic obstructive pulmonary disease (a long-term lung condition)
• People with a confirmed diagnosis of moderate to severe restrictive lung disease (a condition that limits how much the lungs can expand)
• People with a significant history of coronary artery disease (blockages or narrowing of the heart's blood vessels)
• People who have diabetes
• People with active cancer
• People with low blood pressure (systolic blood pressure below 90 mmHg)
• People who need dialysis (kidney replacement therapy)
• People whose medical history shows they responded positively to a specific test called acute vasoreactivity testing (confirm with trial site)
• People who are currently taking, or have taken within the last 3 months, another experimental drug as part of a different study, or who are planning to do so
• People with claustrophobia (fear of enclosed spaces), as the study involves MRI scanning
• People with a permanent cardiac pacemaker or automatic internal cardioverter-defibrillator (implanted heart devices)
• People with certain metal implants in their body, such as a defibrillator, nerve stimulator, hearing aid, or implanted infusion device, which are not compatible with MRI scanning
• People with atrial fibrillation, frequent irregular heartbeats, or any other heart rhythm condition that would interfere with heart MRI imaging
• People with a history of major bleeding
• People whose haemoglobin (a measure of red blood cells) is above the normal upper limit for their age and sex

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