NCT07359599

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

A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%).

Conditions

• Pulmonary Hypertension
• Iron Deficiency

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines
DRUG	Sodium Chloride (NaCl) 0.9 %	Placebo, dosing and administration according to SmPC guidelines

Timeline

• Start date: 2026-01-27
• Primary completion: 2028-07-01
• Completion: 2028-10-01
• First posted: 2026-01-22
• Last updated: 2026-01-30

Locations

7 sites across 1 country: Belgium