Vaccination Against Influenza Pre-discharge in Heart Failure
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 heart-failure
Started Dec 2024
Shorter than P25 for phase_4 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2024
CompletedFirst Posted
Study publicly available on registry
December 10, 2024
CompletedStudy Start
First participant enrolled
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 23, 2025
July 1, 2025
11 months
December 5, 2024
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
6 months
Study Arms (2)
Influenza vaccination
EXPERIMENTALVaccination pre-discharge in patients stabilized after heart failure exacerbation
Standard of care
NO INTERVENTIONInterventions
Influenza vaccination pre-discharge in patients hospitalized due to heart failure exacerbation
Eligibility Criteria
You may qualify if:
- informed consent to participate in the study
- hospitalization (unplanned) due to exacerbation (decompensation) of heart failure
- planned discharge within the next 48 hours due to completion of hospital treatment
- no current (2024/25 season) influenza vaccination.
You may not qualify if:
- severe post-vaccination reaction during influenza vaccination in any previous influenza season
- hypersensitivity to any of the components of the vaccine planned to be administered
- discharge to another hospital for continued treatment or discharge to a nursing home
- antibiotic therapy among the drugs recommended for taking after hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jan Biegus, Professor
Wroclaw Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 5, 2024
First Posted
December 10, 2024
Study Start
December 31, 2024
Primary Completion
November 30, 2025
Study Completion
December 1, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share