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Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major (DFODFPTM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00800761
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 2, 2008
Sponsor:
Collaborator:
Azienda Sanitaria Locale di Cagliari
Information provided by:
Ospedale Microcitemico

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Iron Overload Cardiomyopathy Drug: Deferoxamine and Deferiprone Drug: Deferoxamine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy
Study Start Date : December 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Deferoxamine alone
comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone
 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

Drug: Deferoxamine
deferoxamine vials,40 mg/kg,12 hours/die
Active Comparator: Deferoxamine plus 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups [ Time Frame: 42 months ]

Secondary Outcome Measures :
  1. monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement. [ Time Frame: 42 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cardiomyopathy secondary to iron overload

Exclusion Criteria:

Heart failure

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800761


Locations
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Italy
Adult Talassemic Center, Ospedale Microcitemico
Cagliari, Sardinia, Italy, 09121
Sponsors and Collaborators
Ospedale Microcitemico
Azienda Sanitaria Locale di Cagliari
Investigators
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Study Director: Maria E Lai, MD Department of Internal Medicine, University of Cagliari-Italy
More Information
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Responsible Party: Maria Eliana Lai, Prof, MD, Adult Thalassemic Center, Director, University
ClinicalTrials.gov Identifier: NCT00800761    
Other Study ID Numbers: DFO-DFP in TM
DFOplusDFPLAI
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: December 2, 2008
Last Verified: December 2001
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Thalassemia
beta-Thalassemia
Iron Overload
Cardiovascular Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Deferiprone
Deferoxamine
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Siderophores