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Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

NCT ID: NCT01911871

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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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

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Thalassemia Sickle Cell Disease Myelodysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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thalassemia

patients affected with thalassemia

Blood sample

Intervention Type BIOLOGICAL

a blood sample was taken on the day of inclusion

sickle cell disease

patients affected with sickle cell disease

Blood sample

Intervention Type BIOLOGICAL

a blood sample was taken on the day of inclusion

myelodysplasia

patients affected with myelodysplasia

Blood sample

Intervention Type BIOLOGICAL

a blood sample was taken on the day of inclusion

Interventions

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Blood sample

a blood sample was taken on the day of inclusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariane de montalembert, MD/PhD

Role: STUDY_DIRECTOR

Groupement Hospitalier Necker

Locations

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Hôpital Necker Enfants Malades

Paris, , France

Site Status

Countries

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France

Other Identifiers

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RAF11005

Identifier Type: -

Identifier Source: secondary_id

NI10071

Identifier Type: -

Identifier Source: org_study_id

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