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

NCT ID: NCT00800761

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Overload Cardiomyopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deferoxamine alone

comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone

Group Type ACTIVE_COMPARATOR

Deferoxamine and Deferiprone

Intervention Type DRUG

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

Deferoxamine

Intervention Type DRUG

deferoxamine vials,40 mg/kg,12 hours/die

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

Group Type ACTIVE_COMPARATOR

Deferoxamine and Deferiprone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Deferoxamine

deferoxamine vials,40 mg/kg,12 hours/die

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Cardiomyopathy secondary to iron overload

Exclusion Criteria

Heart failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Locale di Cagliari

OTHER

Sponsor Role collaborator

Ospedale Microcitemico

OTHER

Sponsor Role lead

Responsible Party

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University

Principal Investigators

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Maria E Lai, MD

Role: STUDY_DIRECTOR

Department of Internal Medicine, University of Cagliari-Italy

Locations

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Adult Talassemic Center, Ospedale Microcitemico

Cagliari, Sardinia, Italy

Site Status

Countries

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Italy

References

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Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.

Reference Type DERIVED
PMID: 37975597 (View on PubMed)

Other Identifiers

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DFOplusDFPLAI

Identifier Type: -

Identifier Source: secondary_id

DFO-DFP in TM

Identifier Type: -

Identifier Source: org_study_id