Clinical Trials Directory

Trials / Completed

CompletedNCT01911871

Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Status
Completed
Phase
Study type
Observational
Enrollment
110 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
6 Years
Healthy volunteers
Not accepted

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\*.

Conditions

Interventions

TypeNameDescription
BIOLOGICALBlood samplea blood sample was taken on the day of inclusion

Timeline

Start date
2012-03-01
Primary completion
2014-10-01
Completion
2015-03-01
First posted
2013-07-30
Last updated
2026-02-05

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01911871. Inclusion in this directory is not an endorsement.