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

February 3, 2026 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients affected with thalassemia, SCD, and myelodysplasia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
thalassemia
patients affected with thalassemia
Biological: Blood sample
a blood sample was taken on the day of inclusion
sickle cell disease
patients affected with sickle cell disease
Biological: Blood sample
a blood sample was taken on the day of inclusion
myelodysplasia
patients affected with myelodysplasia
Biological: Blood sample
a blood sample was taken on the day of inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac T2* (MRI)
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver T2*(MRI)
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Novartis
URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Director: Mariane de montalembert, MD/PhD, Groupement Hospitalier Necker

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimated)

July 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI10071
  • RAF11005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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