Vaccination Against Influenza Pre-discharge in Heart Failure

July 18, 2025 updated by: Michał Tkaczyszyn, MD, Wroclaw Medical University

Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 50-556
        • Jan Mikulicz Radecki University Hospital in Wroclaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Experimental: Influenza vaccination
Vaccination pre-discharge in patients stabilized after heart failure exacerbation
Biological: Influenza vaccination
Influenza vaccination pre-discharge in patients hospitalized due to heart failure exacerbation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Investigators

  • Study Chair: Jan Biegus, Professor, Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB 659/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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