NCT01911871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2.6 years

First QC Date

July 26, 2013

Last Update Submit

February 3, 2026

Conditions

ThalassemiaSickle Cell DiseaseMyelodysplasia

Keywords

Thalassemiasickle cell diseasemyelodysplasiatransfusionchelation

Outcome Measures

Primary Outcomes (1)

  • Cardiac T2* (MRI)

    Day 0

Secondary Outcomes (1)

  • Liver T2*(MRI)

    Day 0

Study Arms (3)

thalassemia

patients affected with thalassemia

Biological: Blood sample

sickle cell disease

patients affected with sickle cell disease

Biological: Blood sample

myelodysplasia

patients affected with myelodysplasia

Biological: Blood sample

Interventions

Blood sampleBIOLOGICAL

a blood sample was taken on the day of inclusion

myelodysplasiasickle cell diseasethalassemia

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients affected with thalassemia, SCD, and myelodysplasia

You may qualify if:

  • Thalassemia, sickle cell disease, myelodysplasia
  • having received in the past year \> 8 erythrocyte concentrates
  • \> 6 years of age

You may not qualify if:

  • preexisting cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • de Montalembert M, Ribeil JA, Brousse V, Guerci-Bresler A, Stamatoullas A, Vannier JP, Dumesnil C, Lahary A, Touati M, Bouabdallah K, Cavazzana M, Chauzit E, Baptiste A, Lefebvre T, Puy H, Elie C, Karim Z, Ernst O, Rose C. Cardiac iron overload in chronically transfused patients with thalassemia, sickle cell anemia, or myelodysplastic syndrome. PLoS One. 2017 Mar 3;12(3):e0172147. doi: 10.1371/journal.pone.0172147. eCollection 2017.

    PMID: 28257476RESULT

MeSH Terms

Conditions

ThalassemiaAnemia, Sickle CellAnemia, Refractory, with Excess of Blasts

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAnemia, RefractoryMyelodysplastic SyndromesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mariane de montalembert, MD/PhD

    Groupement Hospitalier Necker

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 30, 2013

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

March 1, 2015

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations

FR(1)