Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-28 @ 12:39 PM
Study NCT ID:
NCT00800761
Status:
COMPLETED
Last Update Posted:
2008-12-02
First Post:
2008-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003676', 'term': 'Deferoxamine'}, {'id': 'D000077543', 'term': 'Deferiprone'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-12', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-01', 'studyFirstSubmitDate': '2008-12-01', 'studyFirstSubmitQcDate': '2008-12-01', 'lastUpdatePostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our primary objective: to assess the prevalence of cardiovascular deaths and hospitalisations for cardiovascular disease in the 2 treatment groups', 'timeFrame': '42 months'}], 'secondaryOutcomes': [{'measure': 'monitor the left ventricular ejection fraction (LVEF) and serum ferritin levels for evidence of improvement.', 'timeFrame': '42 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Overload', 'Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '37975597', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCardiomyopathy secondary to iron overload\n\nExclusion Criteria:\n\nHeart failure'}, 'identificationModule': {'nctId': 'NCT00800761', 'acronym': 'DFODFPTM', 'briefTitle': 'Intensive Combined Chelation Therapy for Iron-Induced Cardiac Disease in Patients With Thalassemia Major', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Microcitemico'}, 'officialTitle': 'Increased Survival and Reversion of Iron-Induced Cardiac Disease in Patients With Thalassemia Major Receiving Intensive Combined Chelation Therapy', 'orgStudyIdInfo': {'id': 'DFO-DFP in TM'}, 'secondaryIdInfos': [{'id': 'DFOplusDFPLAI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Deferoxamine alone', 'description': 'comparison of deferoxamine subcutaneous 40mg/kg/die alone versus combined therapy deferoxamine-deferiprone', 'interventionNames': ['Drug: Deferoxamine and Deferiprone', 'Drug: Deferoxamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deferoxamine plus Deferiprone', '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', 'interventionNames': ['Drug: Deferoxamine and Deferiprone']}], 'interventions': [{'name': 'Deferoxamine and Deferiprone', 'type': 'DRUG', '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', 'armGroupLabels': ['Deferoxamine alone', 'Deferoxamine plus Deferiprone']}, {'name': 'Deferoxamine', 'type': 'DRUG', 'description': 'deferoxamine vials,40 mg/kg,12 hours/die', 'armGroupLabels': ['Deferoxamine alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09121', 'city': 'Cagliari', 'state': 'Sardinia', 'country': 'Italy', 'facility': 'Adult Talassemic Center, Ospedale Microcitemico', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}], 'overallOfficials': [{'name': 'Maria E Lai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Internal Medicine, University of Cagliari-Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Microcitemico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Sanitaria Locale di Cagliari', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Maria Eliana Lai, Prof, MD, Adult Thalassemic Center, Director', 'oldOrganization': 'University'}}}}