Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Completed

• Conditions: Sickle Cell Disease; Myelodysplasia; Thalassemia
• Interventions: Biological: Blood sample

• Registration Number: NCT01911871
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed 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\*.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Primary Completion: 2014-10
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
thalassemia	Blood sample	patients affected with thalassemia
sickle cell disease	Blood sample	patients affected with sickle cell disease
myelodysplasia	Blood sample	patients affected with myelodysplasia

Primary Outcome Measures

Name	Time	Method
Cardiac T2* (MRI)	Day 0

Secondary Outcome Measures

Name	Time	Method
Liver T2*(MRI)	Day 0

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France