Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Sickle Cell Disease Clinical Trial

— SUFEMYO  

Official title:

Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911871
• Other study ID #: NI10071
• Secondary ID: RAF11005
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: April 9, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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*.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Iron Overload
• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia
• Sickle Cell Disease
• Thalassemia

Intervention

Biological:
• Blood sample
a blood sample was taken on the day of inclusion

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac T2* (MRI)		Day 0	No
Secondary	Liver T2*(MRI)		Day 0	No