Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
Information source: Ospedale Microcitemico
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Iron Overload; Cardiomyopathy
Intervention: Deferoxamine and Deferiprone (Drug); Deferoxamine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ospedale Microcitemico Official(s) and/or principal investigator(s): Maria E Lai, MD, Study Director, Affiliation: Department of Internal Medicine, University of Cagliari-Italy
Summary
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.
Clinical Details
Official title: Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups
Secondary outcome: monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Cardiomyopathy secondary to iron overload
Exclusion Criteria:
Heart failure
Locations and Contacts
Adult Talassemic Center, Ospedale Microcitemico, Cagliari, Sardinia 09121, Italy
Additional Information
Starting date: December 2001
Last updated: December 1, 2008
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