Transferrin Saturation and Asthenia in Hemochromatosis (HEMOSAT)
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|ClinicalTrials.gov Identifier: NCT03356548|
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : July 31, 2019
|Condition or disease|
The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload.
Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia <50 by performing weekly bleeds.
The second phase, called maintenance, aims to maintain this ferritinemia <50 by performing bleeding every 1 to 6 months depending on the case.
The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels <50. This could reflect an incomplete control of their disease, and leads us to raise two points:
- It is known that in some subjects, the Transferrin Saturation Coefficient remains high, despite ferritinemia <50; it is also known that this elevation of the Transferrin Saturation Coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1.
- The asthenia observed in some patients in the maintenance phase could be linked to a high rate of Transferrin Saturation Coefficient.
Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .
|Study Type :||Observational|
|Actual Enrollment :||260 participants|
|Official Title:||Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis|
|Actual Study Start Date :||April 10, 2017|
|Actual Primary Completion Date :||April 9, 2019|
|Actual Study Completion Date :||April 9, 2019|
- Quality of life questionnaire SF 36 [ Time Frame: Through study completion, an average of 3 months ]
- Biological markers : Transferrin Saturation Coefficient [ Time Frame: Through study completion, an average of 3 months ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356548
|Rennes University Hospital|
|Rennes, Britain, France, 35033|
|Principal Investigator:||Fabrice LAINE||Rennes University Hospital|