Pulmonary hypertension (PH) is a serious 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 improves the symptoms mentioned above. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions.
The IRON-PH study will enroll 306 patients with pulmonary hypertension. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).
Patients will be followed for six months after receiving the treatment.
| Title | IRON-PH study: A randomized, double-blind, placebo-controlled, multicentre trial, assessing the impact of ferric carboxymaltose on exercise capacity and functional status in pulmonary hypertension |
| Participants (P) | • ≥18 years of age with Pulmonary Hypertension (PH) • WHO functional class II – IV • Iron deficiency defined as TSAT <21% • Pulmonary hypertension (PH) defined by echocardiography and/or right heart catheterization (RHC) according to definition specific for group 1, group 2 and group 4 PH. |
| Intervention (I) | Ferric carboxymaltose (masked to assure blinding) diluted in 100 ml of NaCl 0.9% administered intravenously over 15 minutes. The individualized dose administration will be determined according to summaries of product characteristics (SmPC) and administered at baseline (and at 4 weeks if applicable [e.g. total dose > 1 gram]). |
| Control (C) | Masked placebo will consist of NaCl 0.9% 100 ml administered intravenously over 15 minutes, with dose frequency similar to the intervention arm to assure blinding. |
| Outcome (O) | Change in 6-minute walking distance from baseline to the 24-week follow-up visit. |
| Trial Design | Double-blind, placebo-controlled, randomized trial |
| Sample Size | 306 patients |
| Trial duration | 33 months |
| Budget | 1.330.000,00 € |
| Sponsor | Ziekenhuizen Oost Limburg (ZOL) |
| Chief Investigator | Prof. dr. Pieter Martens |
| External partners | not applicable |
| Number of participating sites | 7-9 |
