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

NCT00800761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2008-12-02

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Azienda Sanitaria Locale di Cagliari

    collaborator OTHER

  • Ospedale Microcitemico

    lead OTHER

Principal Investigators

  • Maria E Lai, MD · Department of Internal Medicine, University of Cagliari-Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2006-06-30
Completion
2006-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800761 on ClinicalTrials.gov