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 whose pulmonary hypertension (high blood pressure in the lungs) falls into a WHO functional class between II and IV, meaning symptoms range from mild limitations during activity to severe limitations even at rest
• People with iron deficiency, shown by a blood test result (TSAT below 21%) taken no more than 3 months before joining the trial
• People with pulmonary hypertension confirmed by heart ultrasound (echocardiography) and/or a right heart catheterisation procedure, falling into one of these specific groups:
  • Group 1: People diagnosed with idiopathic, hereditary, drug-induced, or connective tissue/congenital heart disease-related pulmonary arterial hypertension, who have been on stable, optimised PAH-specific medications for at least 4 weeks, with echocardiogram showing intermediate or high probability of pulmonary hypertension
  • Group 2: People with pulmonary hypertension linked to left-sided heart disease, with a heart pumping function (LVEF) above 50% on imaging in the past 6 months, stable on diuretic and heart failure medications for at least 4 weeks, and meeting specific echocardiogram or right heart catheterisation measurements (confirm with trial site)
  • Group 4: People with chronic thromboembolic pulmonary hypertension (CTEPH) that cannot be treated with surgery, or where disease has persisted or returned after surgery or balloon procedure and further balloon procedures are not suitable, with echocardiogram showing intermediate or high probability of pulmonary hypertension

Who may not be able to join:

• People whose haemoglobin (a measure of red blood cells) is below 8 g/dL or above 15 g/dL at screening
• People with a ferritin level (an iron storage measure) above 700 ng/mL
• People with a known allergic reaction to any ingredient in the study treatment (ferric carboxymaltose, an intravenous iron medication)
• People whose Group 1 pulmonary hypertension is related to veno-occlusive disease (a specific condition affecting lung blood vessels)
• People whose primary diagnosis is Group 3 pulmonary hypertension (related to lung disease or low oxygen levels)
• People whose primary diagnosis is Group 5 pulmonary hypertension (related to unclear or multiple causes)
• People currently taking iron supplements by mouth or by intravenous infusion at the time of screening
• People currently using or planning to use a mechanical heart support device, or who are listed for a lung or heart transplant
• People who have surgery or a procedure planned that is expected to involve significant blood loss (more than 250 mL)
• People currently on or planning to start kidney dialysis (haemodialysis or peritoneal dialysis) within the next 24 weeks
• People who are unable to attend the required follow-up visits within the required timeframes
• People currently enrolled in another clinical trial involving an investigational (unapproved) treatment
• People with a significant uncorrected heart valve narrowing (aortic stenosis with specific measurements) or severe leaking of a heart valve other than the tricuspid valve (confirm with trial site)
• People whom the trial investigator does not believe are able to complete a 6-minute walk test
• People with an active infection, as assessed by the trial investigator
• People who are pregnant or plan to become pregnant during the trial

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