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Clinical Trials in the EU / 2025-522936-14-00
Completed Phase IV

A randomized, double-blind, placebo-controlled, multicentre trial, assessing the impact of ferric carboxymaltose on exercise capacity and functional status in pulmonary hypertension (IRON-PH)

2025-522936-14-00 · tracked via the Priya Life Science EU tracker
Sponsor
Ziekenhuis Oost Limburg
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
12/12/2025
Enrollment target
306
Sites
Belgium

Condition studied

Pulmonary hypertension, Iron deficiency

Investigational medicinal product(s)

Ferric carboxymaltose 50 mg iron/ml solution for injection/infusionSODIUM CHLORIDE

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Change in 6MWD from baseline to 24 weeks follow-up

Endpoint detail

Change in EQ5D from baseline to 24 weeks follow-up, Change in MLHFQ from baseline to 24 weeks follow-up, Change in FSS from baseline to 24 weeks follow-up, The hazard ratio between treatment arms in developing a composite clinical worsening event in the overall trial population (from first patient visit to last patient visit)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522936-14-00 on CTIS ↗ ← All trials in the EU