ThalassemiaSUFEMYONCT01911871
Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
An observational study of Thalassemia and Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Thalassemia, Sickle Cell Disease, Myelodysplasia
- What is being tested?
- Blood sample
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients affected with thalassemia, SCD, and myelodysplasia
Who may be able to join
- Thalassemia, sickle cell disease, myelodysplasia
- having received in the past year > 8 erythrocyte concentrates
- > 6 years of age
Who cannot join
- preexisting cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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*.
- Conditions
- Thalassemia, Sickle Cell Disease, Myelodysplasia
- Being tested
- Blood sample
- Keywords
- Thalassemia, sickle cell disease, myelodysplasia, transfusion, chelation
- Medical subject headings
- Thalassemia, Anemia, Sickle Cell, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
a blood sample was taken on the day of inclusion
| Study group | Role | What they receive |
|---|---|---|
| thalassemia | patients affected with thalassemia Receives: Biological: Blood sample | |
| sickle cell disease | patients affected with sickle cell disease Receives: Biological: Blood sample | |
| myelodysplasia | patients affected with myelodysplasia Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac T2* (MRI)
Measured: Day 0
Secondary outcomes (1)
Liver T2*(MRI)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Mariane de montalembert, MD/PhD, Study director, Groupement Hospitalier Necker
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911871
- Sponsor's protocol ID
- NI10071
- Other IDs
- RAF11005
- Acronym
- SUFEMYO
- Status last verified
- Jan 2026
- First submitted
- 26 Jul 2013
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28257476
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations
- ClinicalTrials.gov ID
- NCT01911871
- Acronym / sponsor ID
- SUFEMYO / NI10071
- Conditions
- Thalassemia, Sickle Cell Disease, Myelodysplasia
- Keywords
- Thalassemia, sickle cell disease, myelodysplasia, transfusion, chelation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Novartis, URC-CIC Paris Descartes Necker Cochin
- Study start
- Mar 2012 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| thalassemia | – | Biological: Blood samplepatients affected with thalassemia |
| sickle cell disease | – | Biological: Blood samplepatients affected with sickle cell disease |
| myelodysplasia | – | Biological: Blood samplepatients affected with myelodysplasia |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients affected with thalassemia, SCD, and myelodysplasia
Key inclusion criteria (3 listed)
- Thalassemia, sickle cell disease, myelodysplasia
- having received in the past year > 8 erythrocyte concentrates
- > 6 years of age
Key exclusion criteria (1 listed)
- preexisting cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplea blood sample was taken on the day of inclusion | Biological | myelodysplasia, sickle cell disease, thalassemia |
Primary outcome
Cardiac T2* (MRI)
Time frame: Day 0
1 secondary outcome
Liver T2*(MRI)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 28257476de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariane de montalembert, MD/PhD study director
Groupement Hospitalier Necker
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia and Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac T2* (MRI) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01911871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.