Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT04407858
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Complications of Carfilzomib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-05-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-25', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of cardio-vasculo-toxicity of carfilzomib', 'timeFrame': '6 months', 'description': 'Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib.'}], 'secondaryOutcomes': [{'measure': 'Systemic hypertension', 'timeFrame': '6 months', 'description': 'Number of patients with as systemic hypertension'}, {'measure': 'Heart Failure Reduced Ejection Fraction', 'timeFrame': '6 months', 'description': 'Number of patients with Heart Failure and Reduced Ejection Fraction'}, {'measure': 'Heart Failure Preserved Ejection Fraction', 'timeFrame': '6 months', 'description': 'Number of patients with Heart Failure and Preserved Ejection Fraction'}, {'measure': 'Predictors of Cardiotoxicity', 'timeFrame': '6 months', 'description': "Correlation between cardio-vascular toxicity and patients' chacateristics."}, {'measure': 'Impact on outcomes', 'timeFrame': '1 year', 'description': 'Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty.'}, {'measure': 'Safety', 'timeFrame': '1 year', 'description': 'Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adverse drug event'], 'conditions': ['Myeloma', 'Heart Failure', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective cohort of patients starting carfilzomib treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intention to treat by Carfilzomib\n\nExclusion Criteria:\n\n* History of carfilzomib treatment'}, 'identificationModule': {'nctId': 'NCT04407858', 'acronym': 'ICARE', 'briefTitle': 'Cardiovascular Complications of Carfilzomib', 'organization': {'class': 'OTHER', 'fullName': 'European Georges Pompidou Hospital'}, 'officialTitle': 'Insuffisance Cardiaque Sous Carfilzomib: étude Prospective', 'orgStudyIdInfo': {'id': '00011928 ICARE'}}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mariana Mirabel, MD, PhD', 'role': 'CONTACT', 'email': 'mariana.mirabel@aphp.fr', 'phone': '+33156095636'}], 'facility': 'Assistance Publique Hôpitaux de Paris - Centre Université de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Mariana Mirabel', 'role': 'CONTACT', 'email': 'mariana.mirabel@aphp.fr', 'phone': '+33156095636'}], 'overallOfficials': [{'name': 'Mariana Mirabel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hôpitaux de Paris - Université de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mariana Mirabel', 'investigatorAffiliation': 'European Georges Pompidou Hospital'}}}}