HEMOSAT: Transferrin Saturation and Asthenia in Hemochromatosis

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03356548

Collaborator

(none)

260

Enrollment

Location

Actual Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational study.

Condition or Disease	Intervention/Treatment	Phase
Hemochromatoses, Genetic

Detailed 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 .

Study Design

Study Type:

Observational

Actual Enrollment :

260 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis

Actual Study Start Date :

Apr 10, 2017

Actual Primary Completion Date :

Apr 9, 2019

Actual Study Completion Date :

Apr 9, 2019

Outcome Measures

Primary Outcome Measures

Quality of life questionnaire SF 36 [Through study completion, an average of 3 months]
Biological markers : Transferrin Saturation Coefficient [Through study completion, an average of 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rennes University Hospital	Rennes	Britain	France	35033

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator: Fabrice LAINE, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT03356548

Other Study ID Numbers:

35RC17_3067_HEMOSAT

First Posted:

Nov 29, 2017

Last Update Posted:

Jul 31, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hemochromatosis

Hemosiderosis

Asthenia

Study Results

No Results Posted as of Jul 31, 2019