RecruitingPhase 4NCT07359599

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


Sponsor

Ziekenhuis Oost-Limburg

Enrollment

306 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

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%).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving iron through an IV infusion improves exercise ability and quality of life in people with pulmonary hypertension (high blood pressure in the lungs) who also have low iron levels. **You may be eligible if...** - You are 18 or older - You have been diagnosed with pulmonary hypertension (confirmed by echocardiogram or heart catheterization) - You have low iron levels in your blood (transferrin saturation below 21%) - Your pulmonary hypertension falls into WHO Group 1 (pulmonary arterial hypertension), Group 2 (heart failure-related), or Group 4 (chronic blood clot-related, inoperable) - You are on stable treatment for your condition - Your symptoms fall within WHO functional class II–IV **You may NOT be eligible if...** - Your iron levels have been checked more than 3 months ago and are out of date - You have a type of pulmonary hypertension not covered by the eligible groups - Your heart's pumping function on the left side is severely impaired - You have contraindications to iron infusions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFerric Carboxymaltose (FCM)

Ferric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines

DRUGSodium Chloride (NaCl) 0.9 %

Placebo, dosing and administration according to SmPC guidelines


Locations(7)

AZORG

Aalst, Belgium

Hôpital Erasme

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium

CHU Charleroi-Chimay

Lodelinsart, Belgium

CHU UCL Namur

Yvoir, Belgium

View Full Details on ClinicalTrials.gov

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NCT07359599


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