About this trial
Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited.
More than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH.
Intravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions.
As part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).
Eligibility criteria
Qualifiers
≥18 years of age
WHO functional class II - IV
Iron deficiency defined as TSAT <21% (no more than ≥3 months old at randomization)
Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization.
Disqualifiers
Screening haemoglobin < 8 g/dl or >15 g/dl
Ferritin > 700 ng/mL
Known hypersensitivity reaction to any component of FCM
Group 1 PH associated with veno-occlusive diseases.
Trial design
Treatments tested in this trial
- Ferric Carboxymaltose (FCM)
- Sodium Chloride (NaCl) 0.9 %
Treatment groups
Sponsors and collaborators
Ziekenhuis Oost-Limburg
Lead sponsor
Federal Knowledge Centre (KCE)
Collaborator