NCT07617376

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Nov 2025Jul 2027

Study Start

First participant enrolled

November 12, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Myocardial InfarctionDecompensated Chronic Heart FailureAcute Heart Failure (AHF)Pulmonary Embolism AcuteHypertension EmergencyArrhythmias

Keywords

influenza vaccinationacute cardiac emergenciespre-discharg vaccination

Outcome Measures

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.

    6 months

Study Arms (2)

Standard of care

NO INTERVENTION

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

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

EXPERIMENTAL

pre-discharge influenza vaccine administration

Biological: Influenza vaccination

Interventions

Influenza vaccinationBIOLOGICAL

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jan Mikulicz Radecki University Hospital in Wroclaw

Wroclaw, 50-556, Poland

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionArrhythmias, CardiacInfluenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jan Biegus, Professor

    Wroclaw Medical University

    STUDY CHAIR

Central Study Contacts

Piotr Kübler Kübler, Professor

CONTACT

48717364240piotr.kubler@umw.edu.pl

Michal Tkaczyszyn, M.D., PhD

CONTACT

48 71 733 11 12michal.tkaczyszyn@umw.edu.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 1, 2026

Study Start

November 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)