Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions

May 20, 2026 updated by: Michał Tkaczyszyn, MD, Wroclaw Medical University

Patients hospitalized for acute cardiac conditions-including acute myocardial infarction, acute heart failure, pulmonary embolism, arrhythmias, and hypertensive emergencies-represent a heterogeneous population at very high risk of recurrent cardiovascular events. Influenza infection may act as a trigger for adverse cardiovascular events. Given the persistently low influenza vaccination uptake despite evidence-based benefits observed in vulnerable populations, including patients with cardiac conditions, new strategies to improve vaccination coverage are being explored. Recently, increasing attention has been directed toward an approach already used in fields such as neonatology, where vaccinations are administered prior to hospital discharge.

In this investigator-initiated, single-center, randomized, open-label interventional study, we will evaluate whether influenza vaccination administered within 24 hours before hospital discharge in patients hospitalized for acute cardiac conditions is safe and effective in reducing subsequent infections, cardiovascular events, and mortality during the 6 months following hospitalization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

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 Contact

Study Contact Backup

Study Locations

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:

  • Acute cardiac hospitalization,
  • Planned discharge home within the next 48 hours following completion of in-hospital treatment,
  • No prior influenza vaccination for the current influenza season.

Exclusion Criteria:

  • History of a severe adverse reaction to influenza vaccination,
  • Allergy to any component of the vaccine to be administered,
  • Discharge to another hospital for continuation of treatment or discharge to a long-term care facility,
  • Antibiotic therapy to be continued after discharge.

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
standard of care (SOC), including recommendation for influenza vaccination in primary care
Experimental: Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions
pre-discharge influenza vaccine administration
Biological: Influenza vaccination
Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infection, unplanned cardiovascular hospitalization or cardiovascular death
Time Frame: 6 months

For the purposes of the study, infection was defined as an acute illness characterized by at least one of the following symptoms or events:

  • typical symptoms (malaise, fatigue, etc.),
  • self-measured body temperature of 38°C or higher,
  • the need for antipyretic / analgesic medication,
  • medical consultation (e.g. with general practitioner) due to infection,
  • unplanned hospitalization due to infection.
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)

November 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB 355/2025, KB 171/2026
  • IDUB.E261.24.014, NANO-9/RNZP (Other Identifier: Wroclaw Medical University)
  • SUBD.A460.26.014 (Other Identifier: Wroclaw Medical University)

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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