Vaccination Against Influenza Pre-discharge in Heart Failure

NCT ID: NCT06725927

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Influenza vaccination

Vaccination pre-discharge in patients stabilized after heart failure exacerbation

Group Type EXPERIMENTAL

Influenza vaccination

Intervention Type BIOLOGICAL

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

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Influenza vaccination

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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MichaƂ Tkaczyszyn, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Biegus, Professor

Role: STUDY_CHAIR

Wroclaw Medical University

Locations

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Jan Mikulicz Radecki University Hospital in Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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KB 659/2024

Identifier Type: -

Identifier Source: org_study_id

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