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Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01911871
Acronym
SUFEMYO
Enrollment
110
Registered
2013-07-30
Start date
2012-03-01
Completion date
2015-03-01
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplasia, Sickle Cell Disease, Thalassemia

Keywords

Thalassemia, sickle cell disease, myelodysplasia, transfusion, chelation

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\*.

Interventions

BIOLOGICALBlood sample

a blood sample was taken on the day of inclusion

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Novartis
CollaboratorINDUSTRY
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cardiac T2* (MRI)Day 0

Secondary

MeasureTime frame
Liver T2*(MRI)Day 0

Countries

France

Contacts

STUDY_DIRECTORMariane de montalembert, MD/PhD

Groupement Hospitalier Necker

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026