The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension

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%).

NCT Number	NCT07359599
Lead Sponsor	Ziekenhuis Oost-Limburg Collaborators: Federal Knowledge Centre (KCE)
Conditions	Pulmonary Hypertension, Iron Deficiency
Enrollment	306 participants
Start Date	2026-01-27
Primary Completion	2028-07 (estimated)
Study Completion	2028-10 (estimated)
Updated on ClinicalTrials.gov	2026-01-30