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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg

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

306 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ziekenhuis Oost-Limburg

Lead sponsor

Federal Knowledge Centre (KCE)

Collaborator