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)
EU CTIS ID: 2025-522936-14-00
What this study is testing
The primary objective is to determine if in patients with pulmonary hypertension that are suffering from iron deficiency treatment with FCM with dosing defined according to the SmPC in comparison to matching placebo leads to a significant improvement in exercise capacity measured as the change in 6 minute walking distance from baseline to 24 weeks of follow-up.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥18 years of age
- WHO functional class II – IV
- Iron deficiency defined as TSAT <21% (no more than ≥3 months old at randomization)
- PH defined by echocardiography and/or right heart catheterization (RHC) according to the following WHO groups: - Group 1 PH: • Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines. - Group 2 PH and baseline LVEF > 50% on imaging modality within last 6 months before randomization and on stable doses of loop diuretics and HFpEF therapies for 4 weeks. Group 2 PH can be included based on echocardiography or RHC.: • Echocardiography (<6mo before randomization): - Presence of LVH or LA-enlargement - E/e’ >15 (at rest or exercise) - TRVmax >2.8 m/s (at rest) or mPAP/CO>3 mHg/L/min (exercise) or echocardiographic evidence of high or intermediate probability for PH as per 2022 ESC PH guidelines. • RHC (<6mo before randomization) - mPAP > 20 mmHg - PCWP > 15 mmHg at rest or PCWP/CO-slope > 2mmHg/L/min or exercise PCWP>25mmHg, or PCWP 13-15 mmHg with elevation ≥18mmHg after 500 cc Fluid Challenge - Group 4 PH: • Inoperable CTEPH • persistent/recurrent CTEPH (> 1 year after endarterectomy or > 6 months after balloon pulmonary angioplasty) ineligible for balloon pulmonary angioplasty. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.
You likely can't join if
- Screening haemoglobin < 8 g/dl or >15 g/dl
- Haemodialysis or peritoneal dialysis (current or planned within the next 24 weeks)
- Inability to return for follow up visits within the necessary windows
- Concurrently in a study with another investigational product
- Uncorrected moderate to severe aortic stenosis (AVA <1.5cm² and mean gradient >20 mmHg) or severe valvular regurgitation (except tricuspid regurgitation)
- Impression by investigator that patient cannot perform a 6MWT
See the full eligibility criteria
- ≥18 years of age
- WHO functional class II – IV
- Iron deficiency defined as TSAT <21% (no more than ≥3 months old at randomization)
- PH defined by echocardiography and/or right heart catheterization (RHC) according to the following WHO groups: - Group 1 PH: • Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines. - Group 2 PH and baseline LVEF > 50% on imaging modality within last 6 months before randomization and on stable doses of loop diuretics and HFpEF therapies for 4 weeks. Group 2 PH can be included based on echocardiography or RHC.: • Echocardiography (<6mo before randomization): - Presence of LVH or LA-enlargement - E/e’ >15 (at rest or exercise) - TRVmax >2.8 m/s (at rest) or mPAP/CO>3 mHg/L/min (exercise) or echocardiographic evidence of high or intermediate probability for PH as per 2022 ESC PH guidelines. • RHC (<6mo before randomization) - mPAP > 20 mmHg - PCWP > 15 mmHg at rest or PCWP/CO-slope > 2mmHg/L/min or exercise PCWP>25mmHg, or PCWP 13-15 mmHg with elevation ≥18mmHg after 500 cc Fluid Challenge - Group 4 PH: • Inoperable CTEPH • persistent/recurrent CTEPH (> 1 year after endarterectomy or > 6 months after balloon pulmonary angioplasty) ineligible for balloon pulmonary angioplasty. • Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.
- Screening haemoglobin < 8 g/dl or >15 g/dl
- Haemodialysis or peritoneal dialysis (current or planned within the next 24 weeks)
- Inability to return for follow up visits within the necessary windows
- Concurrently in a study with another investigational product
- Uncorrected moderate to severe aortic stenosis (AVA <1.5cm² and mean gradient >20 mmHg) or severe valvular regurgitation (except tricuspid regurgitation)
- Impression by investigator that patient cannot perform a 6MWT
- Active infection as judged by the investigator
- Ferritin > 700 ng/mL
- Known hypersensitivity reaction to any component of FCM
- Group 1 PH associated with veno-occlusive diseases
- Primary diagnosis of group 3 PH
- Primary diagnosis of group 5 PH
- Treatment with oral or other IV iron therapies at screening
- Current or planned mechanical circulatory support or lung/heart transplantation
- Any planned surgery or procedure leading to expected significant blood loss (defined as more than 250 ml = equal to 125mg of iron)
The study team makes the final eligibility decision.
Where it's taking place
- Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.