How iron affects the immune system in HHT

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

This study compares immune cell measures in adults with genetically confirmed HHT grouped by iron status and recent iron treatment. Participants undergo blood tests at enrollment (day 0) and again at three months to measure complete blood count, ferritin, inflammatory markers, and lymphocyte subsets including T cells. Groups include patients with normal ferritin and no recent iron therapy, patients with normal ferritin but recent iron therapy or transfusion, and patients with low ferritin without recent supplementation. The design examines whether iron repletion or recent iron exposure is associated with changes in T-lymphocyte counts and other immunological markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For all three groups:

  * Adult patient diagnosed with HHT (meeting 3 or 4 Curaçao criteria).
  * Documented pathogenic mutation in one of the following genes: ENG, ACVRL1, or MADH4.
  * Patient enrolled in the CIROCO cohort.
  * Written informed consent freely given and signed by the patient.
  * Patient covered by a social security scheme or equivalent.
  * Routine biological follow-up for HHT performed within the 15 days preceding the inclusion visit (complete blood count, reticulocytes, ferritin, CRP, calcium, phosphorus).
* Specific to Group 1:

  * Ferritin \> 25 µg/L
  * No iron supplementation (oral or intravenous) in the past 3 months
  * No red blood cell transfusion in the past 3 months
* Specific to Group 2:

  * Ferritin \> 25 µg/L
  * Ongoing oral iron therapy, or at least one intravenous iron infusion, or at least one red blood cell transfusion within the past 3 months
* Specific to Group 3:

  * Ferritin \< 25 µg/L
  * No iron supplementation (oral or intravenous) in the past 3 months
  * No red blood cell transfusion in the past 3 months

Exclusion Criteria:

* Patients with hemoglobin levels \< 90 g/L.
* Patients with active cancer or recent cancer remission (\< 3 months) that may alter the immune profile.
* Patients with an active infection or recent infection recovery (\< 3 months) that may alter the immune profile.
* Patients with an autoimmune or autoinflammatory disease, either active or recently treated (\< 3 months), requiring immunosuppressive therapy and potentially altering the immune profile.
* Pregnant, postpartum, or breastfeeding women.
* Minors.
* Individuals deprived of liberty by judicial or administrative decision.
* Individuals undergoing psychiatric care.
* Individuals admitted to a healthcare or social institution for reasons other than research participation.
* Adults under legal protection (guardianship, curatorship).
* Individuals participating in another interventional clinical trial with an exclusion period still in effect at the time of pre-inclusion.

Where it's running

• Hôpital Femme-Mère-Enfant
  Bron, Rhone, France Recruiting

Study contacts

• Study coordinator: Alexandre Guilhem, MD
• Email: alexandre.guilhem@chu-lyon.fr
• Phone: 04 27 85 50 40

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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.