Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT03924258
Status:
UNKNOWN
Last Update Posted:
2019-04-23
First Post:
2019-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2019-04-18', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete blood iron status', 'timeFrame': 'One day', 'description': 'ferritin, Transferrin Saturation Factor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Despite its known prevalence in Heart Failure, a recent study conducted by Prof. Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In chronic diseases including Heart Failure, Transferrin Saturation Factor is only performed in about 10% of cases while it is recommended for patients with Heart Failure (French Health High Authority 2011). The purpose of this study is to obtain current data on the prevalence of iron deficiency in France in patients with Heart Failure, applying the recommendations of European Society of Cardiology and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, over 18 years of age\n* Patient present at the hospital on the day of the study\n* Diagnosis of Heart Failure (acute or chronic) regardless of left ventricular ejection fraction (LVEF)\n* Patient with signed consent\n\nExclusion Criteria:\n\n* Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT03924258', 'acronym': 'CARENFER IC', 'briefTitle': 'Study of the Prevalence of Iron Deficiency in Patients With Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'VIFORFRANCE'}, 'officialTitle': 'Study of the Prevalence of Iron Deficiency in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'CARENFER IC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEART FAILURE', 'description': 'Patients with Heart Failure diagnosis', 'interventionNames': ['Diagnostic Test: Iron status testing']}], 'interventions': [{'name': 'Iron status testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sample for iron status testing', 'armGroupLabels': ['HEART FAILURE']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIFORFRANCE', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}