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

NCT07359599 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2026-01-30

No results posted yet for this study

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%).

Conditions

Interventions

DRUG

Ferric Carboxymaltose (FCM)

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

DRUG

Sodium Chloride (NaCl) 0.9 %

Placebo, dosing and administration according to SmPC guidelines

Sponsors & Collaborators

  • Federal Knowledge Centre (KCE)

    collaborator UNKNOWN

  • Ziekenhuis Oost-Limburg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-27
Primary Completion
2028-07-31
Completion
2028-10-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359599 on ClinicalTrials.gov