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

Sponsor
Ziekenhuis Oost-Limburg
Study ID
NCT07359599
Phase
PHASE4
Status
Recruiting
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Conditions

  • Iron Deficiency
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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%).

Key Dates

First listed
Jan 22, 2026
Start date
Jan 27, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Ferric carboxymaltose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in 6MWD [ Time Frame: From baseline to 24 week follow-up ]

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