Actively Recruiting
The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
Led by Ziekenhuis Oost-Limburg · Updated on 2026-01-30
306
Participants Needed
7
Research Sites
139 weeks
Total Duration
On this page
Sponsors
Z
Ziekenhuis Oost-Limburg
Lead Sponsor
F
Federal Knowledge Centre (KCE)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- WHO functional class II to IV
- Iron deficiency defined as transferrin saturation (TSAT) less than 21% measured within 3 months before randomization
- Pulmonary hypertension diagnosed by echocardiography or right heart catheterization according to WHO groups 1, 2, or 4 with specific criteria
- Stable and optimized doses of PAH therapies for at least 4 weeks prior for group 1 PH patients
- Echocardiographic or right heart catheterization evidence supporting PH diagnosis within 6 months prior to randomization
- For group 2 PH, left ventricular ejection fraction greater than 50% and stable therapy for heart failure with preserved ejection fraction for 4 weeks
You will not qualify if you...
- Hemoglobin level less than 8 g/dl or greater than 15 g/dl at screening
- Ferritin level greater than 700 ng/mL
- Known allergy to ferric carboxymaltose components
- Group 1 PH associated with veno-occlusive diseases
- Primary diagnosis of group 3 or group 5 PH
- Receiving oral or intravenous iron therapy at screening
- Current or planned mechanical circulatory support or lung/heart transplant
- Planned surgery or procedure expected to cause significant blood loss (>250 ml)
- Hemodialysis or peritoneal dialysis planned or ongoing within 24 weeks
- Unable to attend follow-up visits within required timeframes
- Participation in another study with investigational products
- Moderate to severe aortic valve stenosis or severe valvular regurgitation (except tricuspid regurgitation)
- Investigator's judgment that participant cannot perform the 6-minute walk test
- Active infection
- Pregnancy or planning pregnancy during the study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
AZORG
Aalst, Belgium, 9300
Not Yet Recruiting
2
Hôpital Erasme
Brussels, Belgium, 1070
Not Yet Recruiting
3
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
4
AZ Groeninge
Kortrijk, Belgium, 8500
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
6
CHU Charleroi-Chimay
Lodelinsart, Belgium, 6042
Not Yet Recruiting
7
CHU UCL Namur
Yvoir, Belgium, 5530
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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