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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

Tracking Information
First Submitted Date July 26, 2013
First Posted Date July 30, 2013
Last Update Posted Date April 10, 2015
Study Start Date March 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2013)
Cardiac T2* (MRI) [ Time Frame: Day 0 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 29, 2013)
Liver T2*(MRI) [ Time Frame: Day 0 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
Official Title Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients affected with thalassemia, SCD, and myelodysplasia
Condition
  • Thalassemia
  • Sickle Cell Disease
  • Myelodysplasia
Intervention Biological: Blood sample
a blood sample was taken on the day of inclusion
Study Groups/Cohorts
  • thalassemia
    patients affected with thalassemia
    Intervention: Biological: Blood sample
  • sickle cell disease
    patients affected with sickle cell disease
    Intervention: Biological: Blood sample
  • myelodysplasia
    patients affected with myelodysplasia
    Intervention: Biological: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 25, 2014)
110
Original Estimated Enrollment
 (submitted: July 29, 2013)
210
Actual Study Completion Date March 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01911871
Other Study ID Numbers NI10071
RAF11005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Novartis
Investigators
Study Director: Mariane de montalembert, MD/PhD Groupement Hospitalier Necker
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date April 2015