Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 3:56 PM
Study NCT ID:
NCT06725927
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-23
First Post:
2024-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccination Against Influenza Pre-discharge in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'influenza', 'vaccination'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'In patients with heart failure (HF), influenza vaccination should be considered to prevent HF hospitalizations. However, vaccination rates among patients with HF are low, in part because of subjective but common concerns about whether patients with such severe disease should be vaccinated. In this randomized, open-label study, we will investigate whether influenza vaccination before discharge in patients stabilized after cardiac decompensation is safe and improves outcomes over a 6-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent to participate in the study\n* hospitalization (unplanned) due to exacerbation (decompensation) of heart failure\n* planned discharge within the next 48 hours due to completion of hospital treatment\n* no current (2024/25 season) influenza vaccination.\n\nExclusion Criteria:\n\n* severe post-vaccination reaction during influenza vaccination in any previous influenza season\n* hypersensitivity to any of the components of the vaccine planned to be administered\n* discharge to another hospital for continued treatment or discharge to a nursing home\n* antibiotic therapy among the drugs recommended for taking after hospitalization.'}, 'identificationModule': {'nctId': 'NCT06725927', 'briefTitle': 'Vaccination Against Influenza Pre-discharge in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure', 'orgStudyIdInfo': {'id': 'KB 659/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Influenza vaccination', 'description': 'Vaccination pre-discharge in patients stabilized after heart failure exacerbation', 'interventionNames': ['Biological: Influenza vaccination']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care'}], 'interventions': [{'name': 'Influenza vaccination', 'type': 'BIOLOGICAL', 'description': 'Influenza vaccination pre-discharge in patients hospitalized due to heart failure exacerbation', 'armGroupLabels': ['Influenza vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-556', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Jan Mikulicz Radecki University Hospital in Wroclaw', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Jan Biegus, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Michał Tkaczyszyn, MD', 'investigatorAffiliation': 'Wroclaw Medical University'}}}}