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 18 or older
• People who have had a confirmed diagnosis of pulmonary arterial hypertension (a type of high blood pressure affecting the lungs, known as PAH Group 1) through a specific heart procedure called a right heart catheterisation, performed at any point before the screening stage
• People whose PAH falls into one of these subtypes: idiopathic (no known cause), heritable (genetic), caused by a drug or toxin, associated with a connective tissue disease, or associated with a congenital heart defect that was surgically repaired at least one year ago
• People whose PAH symptoms are classified as moderate (WHO Functional Class II or III), meaning daily activities cause some or significant limitation
• People who have been on at least two stable background PAH medications for at least 60 days before screening (people on only one background medication may still be considered if there is documented medical evidence that the other two medication classes are not suitable for them)
• Women who could become pregnant must have a negative pregnancy test before starting the study, use highly effective contraception throughout the study and for 16 weeks after the last dose, and agree not to breastfeed or donate eggs or blood during the study and for at least 16 weeks after the last dose
• Male participants must agree to use a condom (latex or non-latex synthetic, not animal membrane) during any sexual contact with a pregnant woman or a woman who could become pregnant, throughout the study and for at least 16 weeks after the last dose, even if they have had a vasectomy; they must also agree not to donate blood or sperm during the study and for 16 weeks after the last dose
• People who are able to attend all required study visits and follow all study requirements
• People who are able to understand the study and provide written consent to participate

Who may not be able to join:

• People whose pulmonary hypertension falls under WHO Groups 2, 3, 4, or 5 (types not related to PAH Group 1)
• People with a physical condition affecting their muscles or joints that prevents them from using a stationary exercise bike
• People whose blood oxygen level at rest is below 88% (people using supplemental oxygen may still be considered if their oxygen level stays at or above 88% after three minutes off oxygen)
• People with specific PAH subtypes including HIV-related PAH, PAH linked to high blood pressure in the liver's portal vein, schistosomiasis-related PAH, or pulmonary veno-occlusive disease (a specific lung vessel condition)
• People whose haemoglobin (red blood cell protein) level is above the normal upper limit for their sex, based on local laboratory testing at screening
• People with a low platelet count (the blood cells that help with clotting) below a specified threshold at the time of enrolment
• People with uncontrolled high blood pressure, shown by a systolic reading above 160 mmHg or diastolic above 100 mmHg while sitting at rest during screening
• People with a low resting blood pressure, with a systolic reading below 90 mmHg at screening
• Women who are pregnant or breastfeeding
• People with significantly reduced kidney function at screening (confirm with trial site)
• People with elevated liver enzyme or bilirubin levels at screening above three times the normal upper limit (the bilirubin rule may not apply if there is a documented history of a condition called Gilbert's syndrome)
• People currently taking part in, or who have recently completed, another clinical trial involving an experimental drug — within 30 days for standard small-molecule drugs, or within five half-lives for biological medicines, before signing the consent form
• People who have had a complete surgical removal of one entire lung
• People with certain lung function test results falling below specified thresholds, either at screening or within the six months before screening (confirm with trial site)
• People with a smoking history of 20 or more pack-years, or anyone who has smoked or vaped within the past three months
• People with a body mass index (BMI) of 40 or above
• People planning to start a new cardiopulmonary rehabilitation exercise programme during the study (people already in a stable maintenance phase of an existing programme who plan to continue throughout the study may still be considered)
• People with a known history of high blood pressure in the liver's portal vein or chronic liver disease, including active hepatitis B or C, or any level of liver impairment classified as mild to severe
• People with a history of restrictive, constrictive, or congestive cardiomyopathy (certain types of heart muscle disease)
• People who have had a specific heart procedure called atrial septostomy within 180 days before screening
• People whose heart rhythm test (ECG) shows a QT interval measurement above 500 ms during screening (confirm with trial site)
• People with a personal or family history of long QT syndrome or sudden cardiac death
• People whose heart pumping function (left ventricular ejection fraction) was recorded as below 45% on a heart scan within the six months before screening
• People who have had a significant coronary heart event — such as a heart attack, coronary stenting, bypass surgery, or cardiac chest pain — within six months before screening (chest pain may not apply as an exclusion if a coronary scan shows no blockages)
• People who have had a stroke within three months before screening
• People with significant disease of the mitral or aortic heart valves, above specified severity thresholds (confirm with trial site)
• People who have received intravenous medications to support heart function (such as dobutamine or dopamine) within 30 days before screening
• People with a known allergy or sensitivity to sotatercept (the study drug) or any of its ingredients or container components

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