Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 7:01 PM
Study NCT ID:
NCT01724450
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.', 'timeFrame': '96 weeks'}], 'secondaryOutcomes': [{'measure': 'Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction.', 'timeFrame': '96 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Heart Failure', 'Cardiotoxicity', 'Biomarkers'], 'conditions': ['Breast Cancer', 'Heart Failure', 'Cardiotoxicity']}, 'referencesModule': {'references': [{'pmid': '35087624', 'type': 'DERIVED', 'citation': 'Wanderley MRB Jr, Avila MS, Fernandes-Silva MM, Cruz FDD, Brandao SMG, Rigaud VOC, Hajjar LA, Filho RK, Cunha-Neto E, Bocchi EA, Ayub-Ferreira SM. Plasma biomarkers reflecting high oxidative stress in the prediction of myocardial injury due to anthracycline chemotherapy and the effect of carvedilol: insights from the CECCY Trial. Oncotarget. 2022 Jan 25;13:214-223. doi: 10.18632/oncotarget.28182. eCollection 2022.'}, {'pmid': '29540327', 'type': 'DERIVED', 'citation': 'Avila MS, Ayub-Ferreira SM, de Barros Wanderley MR Jr, das Dores Cruz F, Goncalves Brandao SM, Rigaud VOC, Higuchi-Dos-Santos MH, Hajjar LA, Kalil Filho R, Hoff PM, Sahade M, Ferrari MSM, de Paula Costa RL, Mano MS, Bittencourt Viana Cruz CB, Abduch MC, Lofrano Alves MS, Guimaraes GV, Issa VS, Bittencourt MS, Bocchi EA. Carvedilol for Prevention of Chemotherapy-Related Cardiotoxicity: The CECCY Trial. J Am Coll Cardiol. 2018 May 22;71(20):2281-2290. doi: 10.1016/j.jacc.2018.02.049. Epub 2018 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.', 'detailedDescription': 'Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies.\n\nInitial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.These patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.\n\nExclusion Criteria:\n\nFailure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers.\n\nPatients with HER 2 expression'}, 'identificationModule': {'nctId': 'NCT01724450', 'acronym': 'Ceccy', 'briefTitle': 'Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.', 'orgStudyIdInfo': {'id': 'Ceccy Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carvedilol', 'interventionNames': ['Drug: Carvedilol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Carvedilol', 'type': 'DRUG', 'description': '50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day', 'armGroupLabels': ['Carvedilol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo similar to the carvedilol up titration but wit no active drug.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Edimar Alcides Bocchi, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute of University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital A.C. Camargo', 'class': 'OTHER'}, {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'phd', 'investigatorFullName': 'Edimar Alcides Bocchi', 'investigatorAffiliation': 'University of Sao Paulo'}}}}