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

Wroclaw Medical University

Status and phase: Enrolling; Phase 4

Conditions: Decompensated Chronic Heart Failure; Acute Heart Failure (AHF); Hypertension Emergency; Pulmonary Embolism Acute; Arrhythmias; Myocardial Infarction

Treatments: Biological: Influenza vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT07617376

KB 355/2025, KB 171/2026

SUBD.A460.26.014 (Other Identifier)

IDUB.E261.24.014, NANO-9/RNZP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Standard of care

No Intervention group

Description:

standard of care (SOC), including recommendation for influenza vaccination in primary care

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

Experimental group

Description:

pre-discharge influenza vaccine administration

Treatment:

Biological: Influenza vaccination