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NCT Number: NCT07617376

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

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.

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Key information

Conditions

Myocardial Infarction Acute Heart Failure (AHF) Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Decompensated Chronic Heart Failure Heart Diseases Hypertension Emergency Infarction Infections Influenza, Human Ischemia Myocardial Ischemia Necrosis Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Acute RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Influenza vaccination

Biological

Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Tkaczyszyn, M.D., PhD

CONTACT

[email protected]

48 71 733 11 12

Piotr Kübler Kübler, Professor

CONTACT

[email protected]

48717364240

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

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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