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RecruitingNCT07617376Updated Jun 1, 2026

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

A Phase 4 interventional study of Influenza vaccination in Myocardial Infarction, Decompensated Chronic Heart Failure and Acute Heart Failure (AHF), sponsored by Wroclaw Medical University. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Wroclaw Medical University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2025, registered May 2026).
  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Myocardial Infarction
  • Decompensated Chronic Heart Failure
  • Acute Heart Failure (AHF)
  • Pulmonary Embolism Acute
  • Hypertension Emergency
  • Arrhythmias

Keywords

  • influenza vaccination
  • acute cardiac emergencies
  • pre-discharg vaccination
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 400 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Wroclaw Medical University is the lead sponsor of 93 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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

Interventions

  • BiologicalInfluenza vaccination

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

06

What researchers measure

Primary outcomes

  1. infection, unplanned cardiovascular hospitalization or cardiovascular death

    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.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07617376
Lead sponsor
Wroclaw Medical University
Responsible party
Michał Tkaczyszyn, MD (Dr, Wroclaw Medical University) — Principal investigator
First posted
Jun 1, 2026
Start date
Nov 12, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Piotr Kübler Kübler, Professor
Contact
piotr.kubler@umw.edu.pl
48717364240
Michal Tkaczyszyn, M.D., PhD
Contact
michal.tkaczyszyn@umw.edu.pl
48 71 733 11 12
Jan Biegus, Professor
study chair · Wroclaw Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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