Trial record 2 of 81 for:    chelation AND heart

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

This study has been completed.
Sponsor:
Collaborator:
ASL Cagliari
Information provided by:
Ospedale Microcitemico
ClinicalTrials.gov Identifier:
NCT00800761
First received: December 1, 2008
Last updated: NA
Last verified: December 2001
History: No changes posted

December 1, 2008
December 1, 2008
December 2001
June 2006   (final data collection date for primary outcome measure)
Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups [ Time Frame: 42 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement. [ Time Frame: 42 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Iron Overload
  • Cardiomyopathy
  • 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 alone
    comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone
    Interventions:
    • Drug: Deferoxamine and Deferiprone
    • Drug: Deferoxamine
  • 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
    Intervention: Drug: Deferoxamine and Deferiprone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

Cardiomyopathy secondary to iron overload

Exclusion Criteria:

Heart failure

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00800761
DFO-DFP in TM, DFOplusDFPLAI
No
Maria Eliana Lai, Prof, MD, Adult Thalassemic Center, Director, University
Ospedale Microcitemico
ASL Cagliari
Study Director: Maria E Lai, MD Department of Internal Medicine, University of Cagliari-Italy
Ospedale Microcitemico
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP