Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations (SUFEMYO)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Thalassemia; Myelodysplasia; Sickle Cell Disease

Treatments: Biological: Blood sample

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01911871

RAF11005

NI10071

Details and patient eligibility

About

The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

Full description

The inevestigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

The investigators will record concomitantly parameters which, according to literature data, may influence the occurrence of this complication, and will look for correlations with these parameters and iron overload (secondary objectives), in each of the 3 cohorts.

14 centres are involved and enrol patients with thalassemia, or sickle cell disease, or myelodysplasia having received in the past year > 8 erythrocyte concentrates, and having had a cardiac MRI. Patients files register the type of the disease, age at the beginning of transfusion and chelation, chelator type and dosage, liver and cardiac T2*.

Enrollment: 110 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thalassemia, sickle cell disease, myelodysplasia
• having received in the past year > 8 erythrocyte concentrates
• > 6 years of age

Exclusion criteria

• preexisting cardiac disease

Trial design

110 participants in 3 patient groups

thalassemia

Description:

patients affected with thalassemia

Treatment:

Biological: Blood sample

sickle cell disease

Description:

patients affected with sickle cell disease

Treatment:

Biological: Blood sample

myelodysplasia

Description:

patients affected with myelodysplasia

Treatment:

Biological: Blood sample