Intravenous iron to improve exercise capacity and quality of life in pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls adults with pulmonary hypertension and iron deficiency (TSAT <21%) and randomizes them to receive intravenous ferric carboxymaltose or saline placebo at specialized Belgian centers. Participants must be WHO functional class II–IV and on stable background therapies where applicable. Outcomes include changes in exercise capacity measured by standardized exercise tests, symptom burden, validated quality-of-life questionnaires, and health economic analyses of cost-effectiveness. Blood iron indices and clinical follow-up visits are performed to monitor response and safety.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria:

* 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
* 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.

Where it's running

• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting
• Azorg
  Aalst, Belgium Not yet recruiting
• Hôpital Erasme
  Brussels, Belgium Not yet recruiting
• AZ Groeninge
  Kortrijk, Belgium Not yet recruiting
• UZ Leuven
  Leuven, Belgium Not yet recruiting
• CHU Charleroi-Chimay
  Lodelinsart, Belgium Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.