Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| 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 € |
Trial team
| Sponsor | Ziekenhuizen Oost Limburg (ZOL) |
| Chief Investigator | Prof. dr. Pieter Martens |
| External partners | not applicable |
| Number of participating sites | 7-9 |
