Phase 1 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 who are at least 18 years old.
• People who are willing and able to follow the study schedule, including visits, treatments, and tests.
• People diagnosed with pulmonary arterial hypertension (PAH) — a condition where blood pressure in the lungs is abnormally high — falling into one of these categories: idiopathic (no known cause), hereditary, caused by certain drugs or toxic substances, associated with a connective tissue disease, or associated with a specific type of heart defect that was surgically corrected at least one year before joining the study.
• People whose PAH diagnosis has been confirmed by a procedure called a right heart catheterization, showing specific measurements: a mean pulmonary artery pressure above 20 mmHg, a wedge pressure of 15 mmHg or below, and a pulmonary vascular resistance above 2.00 wood units.
• People with PAH symptoms rated as Class II or III on the WHO/NYHA scale — meaning they experience some limitation during physical activity, but are comfortable at rest.
• People already on a stable oral PAH treatment (specifically an ERA, PDE5 inhibitor, or sGC stimulator) with no change in dose or regimen in the 30 days before the study begins.
• People who can walk at least 150 metres in a 6-minute walking test.
• People taking other medications that may affect PAH (such as calcium channel blockers or digoxin) at a stable dose for at least 30 days before the study starts.
• People of any sex who agree to use highly effective contraception throughout the entire study period, if there is any possibility of pregnancy.

Who may not be able to join:

• People who have three or more of the following risk factors for left heart problems: a body mass index (BMI) of 30 or above, a history of high blood pressure, or a history of significant coronary artery (heart) disease (confirmed by various tests or procedures).
• People whose breathing tests, taken within 180 days before or during screening, show mild or worse lung disease — specifically a FEV1 (a measure of how much air can be breathed out) below 60% of expected, or a total lung capacity below 60% of expected.
• People who have evidence of blood clots in the lungs, confirmed by specific scans or assessments done at or after the time of PAH diagnosis.
• People with severe chronic liver disease, portal hypertension, cirrhosis, or complications such as a history of bleeding from enlarged veins or episodes of confusion related to liver failure.
• People with a confirmed active hepatitis B or hepatitis C infection.
• People whose liver enzyme levels (ALT or AST) are three or more times the upper limit of normal, or whose total bilirubin is two or more times the upper limit of normal, at the time of screening.
• People with significant kidney problems at screening, defined as a high creatinine level (above 2.5 mg/dL) or a need for dialysis.
• People with a haemoglobin (a measure of red blood cells) below 9 g/dL at screening.
• People with diabetes.
• People whose heart function is rated as Class IV on the NYHA scale — meaning symptoms occur even at rest.
• People who have ever been treated with intravenous or subcutaneous prostacyclin-based medications (such as epoprostenol, treprostinil, or iloprost) before the study begins, except when used during a specific lung test procedure.
• People who have pulmonary veno-occlusive disease (a specific type of lung vessel condition).
• People who have been diagnosed with or treated for cancer within the 5 years before screening — with exceptions for certain non-spreading skin cancers or cervical cancer in situ that has been fully removed.
• People with a history of alcohol or drug misuse within the 6 months before screening.
• People who have started a formal exercise-based heart and lung rehabilitation programme within 90 days before or during the study.
• People who have participated in another interventional clinical trial within 30 days before screening.
• People with any other condition or circumstance that the trial doctor believes could increase health risks or interfere with the study results.
• People with a known allergy to the study drug (Engelgin) or any of its ingredients.
• People whose life expectancy is estimated to be less than 12 months, based on the doctor's assessment.
• People who are pregnant or breastfeeding.

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