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)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522936-14-00

Acronym

Z-2025090

Enrollment

306

Registered

2025-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency, Pulmonary hypertension

Brief summary

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

Detailed description

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)

Interventions

DRUGFerric carboxymaltose 50 mg iron/ml solution for injection/infusion

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in 6MWD from baseline to 24 weeks follow-up	—

Secondary

Measure	Time frame
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)	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026