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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT01911871
• Collaborator: Novartis (Industry)
• Enrollment: 110
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	Phase
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 Design

• 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: Mar 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cardiac T2* (MRI) [Day 0]

Secondary Outcome Measures

1. Liver T2*(MRI) [Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01911871
• Other Study ID Numbers: NI10071; RAF11005
• First Posted: Jul 30, 2013
• Last Update Posted: Apr 10, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Assistance Publique - Hôpitaux de Paris: Thalassemia; sickle cell disease; myelodysplasia; transfusion; chelation
• Additional relevant MeSH terms: Preleukemia; Anemia, Sickle Cell; Thalassemia; Myelodysplastic Syndromes; Iron Overload

Study Results

No Results Posted as of Apr 10, 2015