Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT00333827
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2006-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cell Therapy In Dilated Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043182', 'term': 'Carboxylesterase'}], 'ancestors': [{'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2006-06-05', 'studyFirstSubmitQcDate': '2006-06-05', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increase of the ejection fraction of the left ventricle', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Death by any cause', 'timeFrame': '1 year'}, {'measure': 'Maximum oxygen consumption difference, as measured by ergoespirometry, at six and twelve months in relation to baseline', 'timeFrame': '1 year'}, {'measure': 'Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire', 'timeFrame': '6 month'}, {'measure': 'Difference in NYHA functional class', 'timeFrame': '6 month'}, {'measure': 'Percent number of patients that reached an absolute increase of 5% in ejection fraction', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Dilated Cardiomyopathy', 'stem cells', 'Therapeutics', 'Randomized Controlled Trials'], 'conditions': ['Dilated Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '26392433', 'type': 'RESULT', 'citation': 'Martino H, Brofman P, Greco O, Bueno R, Bodanese L, Clausell N, Maldonado JA, Mill J, Braile D, Moraes J Jr, Silva S, Bozza A, Santos B, Campos de Carvalho A; Dilated Cardiomyopathy Arm of the MiHeart Study Investigators. Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study). Eur Heart J. 2015 Nov 7;36(42):2898-904. doi: 10.1093/eurheartj/ehv477. Epub 2015 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy', 'detailedDescription': 'This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.\n\nThe primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.\n\nHypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of dilated cardiomyopathy according to WHO criteria\n* Syndromic heart failure in functional class III or IV of the NYHA\n* Enrollment and continuous follow-up in cardiac out-patient clinic\n* Adequate medical therapy after optimization therapy\n* Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule\n\nExclusion Criteria:\n\n* Valvular diseases, except functional mitral or tricuspid reflow\n* Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries\n* Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism\n* Sustained ventricular tachycardia\n* Abusive use of alcohol or illicit drugs\n* Pregnancy\n* Use of cardio toxic drugs\n* Any co-morbidity with impact in life expectancy in 2 years\n* Renal function compromised (creatinine above 2 mg/dl)"}, 'identificationModule': {'nctId': 'NCT00333827', 'briefTitle': 'Cell Therapy In Dilated Cardiomyopathy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Brazil'}, 'officialTitle': 'Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy', 'orgStudyIdInfo': {'id': 'EMRTCC-MCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Optimal Therapy', 'description': 'Optimal therapy for cardiac failure', 'interventionNames': ['Drug: optimal therapy for cardiaca failure']}, {'type': 'EXPERIMENTAL', 'label': 'cell therapy', 'description': 'stem cell', 'interventionNames': ['Procedure: cell']}], 'interventions': [{'name': 'optimal therapy for cardiaca failure', 'type': 'DRUG', 'description': 'optimal therapy for cardiaca failure', 'armGroupLabels': ['Optimal Therapy']}, {'name': 'cell', 'type': 'PROCEDURE', 'description': 'stem cell', 'armGroupLabels': ['cell therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22.240-006', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'INCL - National Institute of Cardiology Laranjeiras', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Antonio Carlos C de Carvalho, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INCL'}, {'name': 'Bernardo R Tura, Md,MsC', 'role': 'STUDY_CHAIR', 'affiliation': 'INCL'}, {'name': 'Augusto Z Bozza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Financiadora de Estudos e Projetos', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bernardo Rangel Tura', 'investigatorAffiliation': 'Ministry of Health, Brazil'}}}}