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 between 18 and 75 years old (inclusive) at the time of the screening visit.
• You have been diagnosed with pulmonary arterial hypertension (PAH) — a type of high blood pressure in the lungs — specifically either the type with no known cause (idiopathic), or the type linked to a congenital (from birth) heart condition.
• Your symptoms are classified by your doctor as WHO Functional Class III or IV, meaning your condition significantly limits your physical activity.
• A special heart test called a right heart catheterization has confirmed that the pressure in your lung arteries is high enough and that fluid pressure in a specific part of your heart is within the required range.
• During a 6-Minute Walk Test, you can walk at least 100 meters but no more than 440 meters, and your walking ability remains stable between your first and second study visits.
• You may be new to PAH treatment or already on PAH medications; if you are already on treatment, certain heart pressure measurements must still meet required levels at your second visit.
• You are able to understand what the study involves, are willing to follow study rules, and can give written consent before any study procedures begin.

Who may not be able to join:

• You have been diagnosed with a type of pulmonary hypertension classified as Group 3 or Group 5 (caused by lung disease or other unclear reasons) according to Chinese guidelines.
• A heart ultrasound (echocardiogram) done within the past 6 months shows your heart's pumping function is significantly weakened, or you have a serious heart valve problem or a condition where the sac around the heart is stiff (confirm with trial site).
• You have 3 or more of the following risk factors for heart weakness: a body mass index (BMI) of 30 or above, a history of high blood pressure, any type of diabetes, or a significant history of coronary artery disease (such as a past heart attack, heart bypass surgery, blocked coronary arteries, or a history of chest pain/angina).
• Your blood pressure is very high and uncontrolled at the time of your second study visit (top number 180 or above, or bottom number 110 or above).
• You have a personal history of a heart rhythm problem called long QT syndrome or a dangerous irregular heartbeat called torsades de pointes.
• Your liver enzyme levels (ALT or AST) are 3 or more times higher than the normal range at screening.
• Your kidneys are severely impaired, based on a specific calculation of how well they filter your blood.
• You have severe liver disease (the most serious stage) at screening, are on kidney dialysis, or have had a kidney transplant.
• You have a known problem with blood clotting, whether inherited or caused by another condition (confirm with trial site for specific clotting disorders listed).
• You have a history of serious bleeding or bleeding inside the skull (brain).
• You have a history of increased pressure inside the skull.
• You are currently pregnant or breastfeeding.
• You have had major surgery on your digestive system within the past 12 months, or you have active or past inflammatory bowel disease, in a way the investigator considers significant.
• You have any other medical or surgical condition that the study doctor believes would put you at higher risk or prevent you from completing the trial.
• You are unwilling or unable to safely stop your current PAH medications as required by the study.
• You have had a known allergic or adverse reaction to the study drug or similar drugs.
• You have a history of substance or alcohol misuse within the past year, or the investigator has concerns about your reliability.
• You are directly involved in running this clinical trial.

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