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Completed

NCT Number: NCT01911871

Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

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.

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Key information

Conditions

Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Refractory Anemia, Refractory, with Excess of Blasts Anemia, Sickle Cell Bone Marrow Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Myelodysplasia Myelodysplastic Syndromes Sickle Cell Disease

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker Enfants Malades

Paris, 75015, France

About this study

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*.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

a blood sample was taken on the day of inclusion

Primary outcomes

  1. Cardiac T2* (MRI)

    Time frame: Day 0

Secondary outcomes

  1. Liver T2*(MRI)

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Novartis
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SUFEMYO

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 30, 2013
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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