A Phase 4 interventional study of Deferoxamine and Deferiprone and Deferoxamine in Iron Overload and Cardiomyopathy, sponsored by Ospedale Microcitemico. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-02.
Sponsored by Ospedale Microcitemico · Phase 4, Interventional, and Treatment
Myocardial iron overload is the leading cause of death in patients with beta-thalassemia major (TM). Therapy with deferoxamine (DFO) combined with deferiprone (DFP) reduces myocardial iron and improves cardiac function. However, the prognosis for TM patients with established cardiac disease switched from DFO monotherapy to combined DFP/DFO chelation is unknown. Twenty-eight TM patients with cardiac disease were enrolled in a prospective study lasting 42±6 months. Fifteen (9 high-ferritin and 6 low-ferritin) were placed on DFP/DFO (DFP, 75 mg/kg t.i.d.; DFO, 40-50 mg/kg over 8-12 h at night 5-7 d/wk), while 13 (5 high- and 8 low-ferritin) received DFO alone. No cardiac events were observed among high-ferritin patients on combination therapy, whereas 4 cardiac events (p=0.0049), including three deaths, occurred in high-ferritin patients on DFO monotherapy. These findings demonstrate that in TM patients with well-established cardiac disease combined iron-chelation therapy with DFP/DFO is superior to DFO monotherapy.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
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Cardiomyopathy secondary to iron overload
Exclusion Criteria:
Heart failure
comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone
Drug: Deferoxamine and Deferiprone · Drug: Deferoxamine
comparison of two arms: the first one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die plus deferiprone tablets 75 mg/kg three times/die versus the second one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die
Drug: Deferoxamine and Deferiprone
comparison of two arms: the first one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die plus deferiprone tablets 75 mg/kg three times/die versus the second one treated with deferoxamine subcutaneous vials,40 mg/kg,12 hours/die
deferoxamine vials,40 mg/kg,12 hours/die
Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups
Time frame: 42 months
monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.
Time frame: 42 months
This study is completed, as verified in Dec 2001. You cannot join it, but the record below documents what was studied.
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