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

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ClinicalTrials.gov Identifier: NCT01911871
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : April 10, 2015
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Thalassemia Sickle Cell Disease Myelodysplasia Biological: Blood sample

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
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
Study Start Date : March 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : March 2015


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




Primary Outcome Measures :
  1. Cardiac T2* (MRI) [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Liver T2*(MRI) [ Time Frame: Day 0 ]


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients affected with thalassemia, SCD, and myelodysplasia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911871


Locations
France
Hôpital Necker Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
Study Director: Mariane de montalembert, MD/PhD Groupement Hospitalier Necker

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01911871     History of Changes
Other Study ID Numbers: NI10071
RAF11005
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Thalassemia
sickle cell disease
myelodysplasia
transfusion
chelation

Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Iron Overload
Myelodysplastic Syndromes
Preleukemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms