Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07359599

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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