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

NCT07617376 — Phase 4, Recruiting, 400 participants, Wroclaw Medical University
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RegistryNCT07617376
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment400 (Estimated)
SponsorWroclaw Medical University (Other)
ConditionsMyocardial Infarction, Decompensated Chronic Heart Failure, Acute Heart Failure (AHF), Pulmonary Embolism Acute, Hypertension Emergency, Arrhythmias
InterventionsInfluenza vaccination (Biological)
Datesstart 2025-11-12, primary completion 2026-12-31 (estimated), completion 2027-07-01 (estimated), first posted 2026-06-01, last updated 2026-06-01
Locations1 site in Poland

Related Papers Related Patents Related Grants Related Experts
All trials for Myocardial Infarction All trials for Decompensated Chronic Heart Failure All trials of Influenza vaccination

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Standard of careNo interventionstandard of care (SOC), including recommendation for influenza vaccination in primary care
Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditionsExperimentalBiological: Influenza vaccinationpre-discharge influenza vaccine administration
  • Influenza vaccination (Biological): Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions

+Outcome measures

Primary outcomes

  • infection, unplanned cardiovascular hospitalization or cardiovascular death [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Jan Mikulicz Radecki University Hospital in WroclawWroclawPolandRecruiting

+Investigators