Back to resultsIntensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major (DFODFPTM)
Primary Purpose
Iron Overload, Cardiomyopathy
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Deferoxamine and Deferiprone
Deferoxamine
Sponsored by
About this trial
This is an interventional treatment trial for Iron Overload
Eligibility Criteria
Inclusion Criteria:
Cardiomyopathy secondary to iron overload
Exclusion Criteria:
Heart failure
Sites / Locations
- Adult Talassemic Center, Ospedale Microcitemico
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Deferoxamine alone
Deferoxamine plus Deferiprone
Arm Description
comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-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
Outcomes
Primary Outcome Measures
Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups
Secondary Outcome Measures
monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.
Full Information
NCT ID
NCT00800761
First Posted
December 1, 2008
Last Updated
December 1, 2008
Sponsor
Ospedale Microcitemico
Collaborators
Azienda Sanitaria Locale di Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT00800761
Brief Title
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
Acronym
DFODFPTM
Official Title
Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ospedale Microcitemico
Collaborators
Azienda Sanitaria Locale di Cagliari
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Overload, Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Arm Title
Deferoxamine alone
Arm Type
Active Comparator
Arm Description
comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone
Arm Title
Deferoxamine plus Deferiprone
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Deferoxamine and Deferiprone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Deferoxamine
Intervention Description
deferoxamine vials,40 mg/kg,12 hours/die
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.
Time Frame
42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiomyopathy secondary to iron overload
Exclusion Criteria:
Heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria E Lai, MD
Organizational Affiliation
Department of Internal Medicine, University of Cagliari-Italy
Official's Role
Study Director
Facility Information:
Facility Name
Adult Talassemic Center, Ospedale Microcitemico
City
Cagliari
State/Province
Sardinia
ZIP/Postal Code
09121
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
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