Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis

  • STATUS
    Recruiting
  • End date
    May 26, 2025
  • participants needed
    240
  • sponsor
    Rennes University Hospital
Updated on 26 July 2021

Summary

Patients in maintenance treatment for HFE hemochromatosis since at least one year will be included in a two year study period and randomized in two groups experimental and control group. Because proton pump inhibitors are widely used as chronic medication, and because they can significantly modify iron absorption, patients will be stratified according to the use of proton pump inhibitors and gender. A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients. Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group (patients treated with bloodletting according to current guidelines "ferritin alone" versus patients treated with bloodletting according to "transferrin saturation and serum ferritin").Blood count and iron metabolism parameters will be performed at each bloodletting and follow-up visits. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit. Volume and schedule for bloodlettings will be determined according to guidelines specifically designed for this study to assure harmonization of treatment management, and centrally validated through the recording of the biological tests in the electronic Case Report Form which will provide the investigator with the volume and schedule of the next bloodletting. There will be two ways of treatment modification: either change of schedule or volume of bloodletting. Patients will undergo follow-up visit every six months with clinical examination, questionnaires at J0, M12 and M24 (SF-36; AIMS2-SF, WOMAC, EQ-5D-5L), and biological test. For health economics analysis, data will be obtained thanks to a dedicated extraction from SNDS database SNDS database will allow to gather hospital stays, visits, and other healthcare-related costs as well as vital status (date (month/year) of death) and cause of death. A de-identified copy of the clinical database, restricted to the relevant variables, will be sent for semideterministic matching purpose with SNDS extraction using four key variables: gender, same date (month/year) of birth, same date (day/month/year) of visit for bloodletting; pending, of course, regulatory authorization.

Details
Condition Hemochromatosis
Treatment Clinical examination, Biobank, SF36 questionnaire, AIMS2_SF questionnaire, WOMAC questionnaire, EQ-5D-5L questionnaire, Blood Sample Complete blood count, Blood Sample Iron panel, Blood Sample Fasting Glucose, Blood sample lipid panel, Blood sample liver panel, Blood sample C reactive protein, Bloodletting - control group, Medico-economical, Bloodletting - experimental group
Clinical Study IdentifierNCT04779593
SponsorRennes University Hospital
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\- Patients treated with iron chelators
Patients treated with erythroid growth factors (erythropoietin)
Patient with excessive alcohol consumption (> 20g/day and > 30 g/day for women and men respectively)
Patients with chronic haematological condition
Patients having uncontrolled chronic blood loss (of digestive or gynaecological origin)
Patients with chronic kidney failure
Patients with a diagnosis of cancer or history of cancer in the last year
Pregnancy or breast feeding
Patient who are included in another research protocol
Adults legally protected (judicial protection, guardianship, or supervision), persons deprived of their freedom
with C282Y homozygous HFE hemochromatosis
having finished the initial phase of HFE hemochromatosis treatment and in maintenance treatment for at least one year
having signed an informed consent form

Exclusion Criteria

Patients treated with iron chelators
Patients treated with erythroid growth factors (erythropoietin)
Patient with excessive alcohol consumption (> 20g/day and > 30 g/day for women and men respectively)
Patients with chronic haematological condition
Patients having uncontrolled chronic blood loss (of digestive or gynaecological origin)
Patients with chronic kidney failure
Patients with a diagnosis of cancer or history of cancer in the last year
Pregnancy or breast feeding
Patient who are included in another research protocol
Adults legally protected (judicial protection, guardianship, or supervision), persons deprived of their freedom
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