Pulmonary HypertensionPhase 4IRON-PHNCT07359599
The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension
A Phase 4 study testing Ferric Carboxymaltose (FCM) and Sodium Chloride (NaCl) 0.9 % in people with Pulmonary Hypertension and Iron Deficiency, run by Ziekenhuis Oost-Limburg at 7 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Iron Deficiency
- What is being tested?
- Ferric Carboxymaltose (FCM) and Sodium Chloride (NaCl) 0.9 %
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 7 sitesBelgium
- Study dates
- 27 Jan 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
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- 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.
Who cannot join
- Screening haemoglobin < 8 g/dl or >15 g/dl
- 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
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- 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).
- 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.
- Pregnancy or desire to become pregnant during the study duration.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Belgium7 sites, 7 recruiting
- Not yet recruiting
AZORG
Aalst, 9300
Kathy De Knijf, +3253724449, kathy.de.knijf@AZORG.be
Jeroen Dauw
- Not yet recruiting
Hôpital Erasme
Brussels, 1070
Frederic Gayet, +3225558106, frederic.gayet@hubruxelles.be
Jean-Luc Vachiery
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Julie Bollen, +3289807251, julie.bollen@zol.be
Pieter Martens
- Not yet recruiting
AZ Groeninge
Kortrijk, 8500
Helena Vandenbroeke, +3256636353, studieslongziekten@azgroeninge.be
Mathias Leys
- Not yet recruiting
UZ Leuven
Leuven, 3000
Margo Vangrunderbeek, +3216346842, margo.vangrunderbeek@uzleuven.be
Marion Delcroix
- Not yet recruiting
CHU Charleroi-Chimay
Lodelinsart, 6042
Aya El Houri, +3271922249, aya.elhouri@humani.be
Simina Ciurica
- Not yet recruiting
CHU UCL Namur
Yvoir, 5530
Fabien Dormal, +3281423658, fabien.dormal@chuuclnamur.uclouvain.be
Fabian Demeure
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension
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.
Read more
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
- Pulmonary Hypertension, Iron Deficiency
- Being tested
- Ferric Carboxymaltose (FCM), Sodium Chloride (NaCl) 0.9 %
- Medical subject headings
- Hypertension, Pulmonary, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
Ferric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines
Sodium Chloride (NaCl) 0.9 %Drug
Placebo, dosing and administration according to SmPC guidelines
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Experimental | Not described Receives: Drug: Ferric Carboxymaltose (FCM) |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium Chloride (NaCl) 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6MWD
Change in 6-minute walking distance (6MWD) from baseline to 24 week follow-up
Measured: From baseline to 24 week follow-up
Secondary outcomes (4)
Change in MLHFQ
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 24 week follow-up.
Total Score: Sum of all 21 items (0-105) Higher Score = Worse QoL: A higher number indicates a greater negative impact from heart failure Lower Score = Better QoL: A lower score suggests less limitation
Measured: Baseline to 24 week follow-up
Change in EQ5D5L
Change in EuroQol 5 dimensions - 5 levels questionnaire score from baseline to 24 week follow-up EQ-5D-5L combiines responses from five health dimensions, each with five severity levels to create a 5-digit health state code, then applying country-specific "value sets" (valuation matrices) to convert this code into a single Index Score (Utility Score), ranging from <0 (worst) to 1 (best health), plus a separate EQ-VAS score (0-100) for overall self-rated health.
Dimensions: Mobility, self-care, usual activities, pain/discomfort, anxiey/depression Levels: 1 no problem, 2 slight problems, 3 moderate problems, 4 severe problems, 5 unable to/extreme problems Example of 5-digit state code: 12345 indicates no problems with mobility, slight problems with self-care, moderate problems with usual activities, severe pain/discomfort and extreme anxiety/depression
Measured: Baseline to 24 week follow-up
Change in FSS
Change in Fatigue Severity Scale (FSS) score from baseline to 24 weeks Total score: sum of all scores (ranging between 9 - 63) Higher Scores = More Fatigue Lower Scores = Less Fatigue
Measured: Baseline to 24 week follow-up
Developing composite clinical worsening event
The hazard ratio between treatment arms in developing the composite clinical worsening event in the overall trial population
Measured: From first patient Day 1 (Baseline) to study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start27 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Knowledge Centre (KCE)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359599
- Sponsor's protocol ID
- Z-2025090
- Other IDs
- 2025-522936-14-00, 2025
- Acronym
- IRON-PH
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07359599
- Acronym / sponsor ID
- IRON-PH / Z-2025090
- Conditions
- Pulmonary Hypertension, Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Federal Knowledge Centre (KCE)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric Carboxymaltose (FCM) |
| Placebo | Placebo comparator | Drug: Sodium Chloride (NaCl) 0.9 % |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥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:
Key exclusion criteria (16 listed)
- Screening haemoglobin < 8 g/dl or >15 g/dl
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose (FCM)Ferric Carboxymaltose (FCM), dosing and administration according to SmPC guidelines | Drug | Ferric carboxymaltose |
| Sodium Chloride (NaCl) 0.9 %Placebo, dosing and administration according to SmPC guidelines | Drug | Placebo |
Primary outcome
Change in 6MWD
Time frame: From baseline to 24 week follow-up
Change in 6-minute walking distance (6MWD) from baseline to 24 week follow-up
4 secondary outcomes
Change in MLHFQ
Time frame: Baseline to 24 week follow-up
Change in EQ5D5L
Time frame: Baseline to 24 week follow-up
Change in FSS
Time frame: Baseline to 24 week follow-up
Developing composite clinical worsening event
Time frame: From first patient Day 1 (Baseline) to study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Carboxymaltose (FCM) and Sodium Chloride (NaCl) 0.9 % in people with Pulmonary Hypertension and Iron Deficiency, run by Ziekenhuis Oost-Limburg at 7 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6MWD (time frame: From baseline to 24 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.