Pulmonary Hypertension Trial, Recruiting

Written by an AI model from the 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 to 80 years old who weigh at least 40 kg (about 88 pounds).
• People whose pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) falls into a functional category rated I, II, or III by their doctor, meaning their symptoms range from no limitations to mild-to-moderate limitations on physical activity.
• People diagnosed with one of these specific types of pulmonary arterial hypertension (PAH): idiopathic PAH (no known cause), hereditary PAH, or PAH linked to connective tissue diseases (such as scleroderma or lupus), certain drug or toxin exposure, or a corrected congenital heart defect that was repaired more than one year ago (such as a hole in the heart).
• People assessed as low-risk or intermediate-risk according to specific 2022 international guidelines for PAH (confirm with trial site).
• People whose right heart catheterization results (a specialised heart test) show specific measurements: average pressure in the pulmonary artery of at least 25 mmHg, pulmonary vascular resistance of at least 3 Wood units, and pulmonary artery wedge pressure of 15 mmHg or below — measured using an approved method (thermal dilution or direct Fick method only).
• People whose lung function tests show: total lung capacity at least 60% of the expected normal value, forced expiratory volume in one second at least 55% of the expected normal value, and a specific measure of gas exchange (DLCO_SB) at least 40% of the expected normal value.
• People who can walk more than 100 metres in a 6-minute walk test, confirmed on two separate occasions during screening (at least 4 hours apart, within one week), with both results within 15% of each other.
• People whose blood oxygen level (measured at rest, without extra oxygen) is 88% or higher.
• People who have not taken part in any heart or lung rehabilitation programme in the 12 weeks before screening.
• Women who could become pregnant must agree to use contraception for the entire duration of the study.
• People who are able to understand the study consent form and sign it.

Who may not be able to join:

• People with other types of pulmonary hypertension not listed above, such as HIV-related PAH, schistosomiasis-related PAH, PAH linked to high blood pressure in the liver (portal hypertension), or rare conditions affecting the lung blood vessels (pulmonary vein occlusive disease or pulmonary capillary hemangiomatosis).
• People with pulmonary hypertension caused by blood clots in the lungs (chronic thromboembolic pulmonary hypertension, also called Group 4 PH).
• People with pulmonary hypertension caused by left heart disease (Group 2 PH).
• People with pulmonary hypertension caused by lung disease or low oxygen levels (Group 3 PH).
• People with pulmonary hypertension that has unclear or multiple causes (Group 5 PH).
• People who have received PAH-specific treatments — such as PDE5 inhibitors, ERAs, or ongoing prostacyclin therapy — within the 4 weeks before screening.
• People who have previously taken an ERA (such as macitentan) or a PDE5 inhibitor (such as sildenafil) and stopped because of side effects unrelated to liver problems.
• People with a known allergy to the study drug, its breakdown products, or its ingredients.
• People who have received intravenous heart-stimulating medications (such as dobutamine) within 2 weeks before screening.
• People currently taking protease inhibitors, systemic ketoconazole, or systemic itraconazole (certain antifungal or antiviral medicines).
• People currently taking strong CYP3A4 inducers, such as rifampicin (a type of antibiotic) (confirm with trial site).
• People who have had unstable or changing doses of calcium channel blockers or statins (cholesterol-lowering medicines) within the 4 weeks before screening.
• People with a history of chest pain (angina) or who have taken nitrate medications (short- or long-acting) in the 12 weeks before screening.
• People whose liver enzyme blood test results (ALT or AST) are more than twice the upper limit of the normal range at screening.
• People whose bilirubin blood test result is more than 1.5 times the upper limit of the normal range at screening.
• People with severe kidney problems, defined by a specific kidney function measurement below 45 mL/min/1.73m² at screening.
• People with severe liver disease (classified as Child-Pugh Class C, with or without cirrhosis).
• People with significant anaemia (low red blood cell levels), as judged by the trial doctor.
• People with a history of bleeding disorders or significant active stomach ulcers.
• People with uncontrolled high blood pressure (at or above 180/110 mmHg) at screening.
• People with very low blood pressure (below 90/50 mmHg) at screening.
• People who have had a heart attack within the 3 months before screening.
• People with serious heart conditions, including significant valve disease, constrictive pericarditis, certain types of heart muscle disease, life-threatening heart rhythm problems, significant weakness of the left side of the heart, blockage of blood flow out of the left heart, symptomatic coronary artery disease, fainting due to blood pressure changes, or circulatory failure.
• People with a history of a specific eye condition called non-arteritic anterior ischemic optic neuropathy (a type of vision loss affecting the optic nerve).
• People with an inherited degenerative eye disease, such as retinitis pigmentosa.
• People with significant fluid retention (build-up of fluid in the body), as judged by the trial doctor.
• People with serious conditions affecting the heart, liver, kidneys, blood, digestive system, immune system, hormones, metabolism, or nervous system that the trial doctor believes could affect safety or the study results.
• People who have had a cancer diagnosis in the past 5 years, except for certain limited, non-spreading skin cancers, cervical carcinoma in situ, or prostate cancer — provided those people are not expected to need radiotherapy, chemotherapy, surgery, or hormonal treatment during the study (confirm with trial site).
• Women who are pregnant or breastfeeding.
• People who have a history of not following medical instructions or treatment plans, as judged by the trial team.
• People with a history of alcohol abuse or use of illegal drugs within the past year.
• People who have taken part in another clinical trial involving an investigational drug or device within the 4 weeks before screening.

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