Vaccination Against Influenza Pre-discharge in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jan Mikulicz Radecki University Hospital in Wroclaw

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influenza vaccination

Biological

Influenza vaccination pre-discharge in patients hospitalized due to heart failure exacerbation

Primary outcomes

Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 10, 2024
Registry last updated: Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not Yet Recruiting