Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Tr… (NCT00673608) | Clinical Trial Compass
CompletedPhase 4
Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload
Australia118 participantsStarted 2007-11
Plain-language summary
This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients ≥ 18 years and weighing \>40kg.
* Lifetime minimum of \> 20 units of packed red blood cell transfusions
* Normal or minimally abnormal cardiac function
Exclusion criteria:
* Contraindication to MRI scans
* High risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease
* Patients with uncontrolled high blood pressure
* An organ transplant less than 3 months previously
Other protocol-defined inclusion/exclusion criteria may apply.
What they're measuring
1
Change in cardiac iron load and cardiac ejection fraction by MRI recorded at baseline and after 53 weeks.