Transferrin Saturation and Asthenia in Hemochromatosis

Hemochromatoses, Genetic Clinical Trial

— HEMOSAT  

Official title:

Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356548
• Other study ID #: 35RC17_3067_HEMOSAT
• Status: Completed
• Start date: April 10, 2017
• Est. completion date: April 9, 2019

Study information

• Verified date: July 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study.

Description:

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion criteria:

• homozygous C282Y ;

• in the maintenance phase for at least 6 months ;

• follow-up at Rennes University Hospital ;

• patient who has not expressed his opposition to participate in the study.

• Exclusion criteria:

• Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ;

• Temporary: infectious syndrome within 7 days before bleeding.

Related Conditions & MeSH terms

• Asthenia
• Hemochromatoses, Genetic
• Hemochromatosis

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Britain

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life questionnaire SF 36		Through study completion, an average of 3 months
Primary	Biological markers : Transferrin Saturation Coefficient		Through study completion, an average of 3 months