Myocardial InfarctionPhase 4NCT07617376
Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions
A Phase 4 study testing Influenza vaccination in people with Myocardial Infarction and Decompensated Chronic Heart Failure, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Decompensated Chronic Heart Failure, Acute Heart Failure (AHF)
- What is being tested?
- Influenza vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 12 Nov 2025to 1 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, 50-556
Michal Tkaczyszyn, M.D, PhD, 48 71 733 11 12, michal.tkaczyszyn@umw.edu.pl
Kamila Florek, M.D., 71 733 11 12, kamila.florek@student.umw.edu.pl
About this study
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.
- Conditions
- Myocardial Infarction, Decompensated Chronic Heart Failure, Acute Heart Failure (AHF), Pulmonary Embolism Acute, Hypertension Emergency, Arrhythmias
- Being tested
- Influenza vaccination
- Keywords
- influenza vaccination, acute cardiac emergencies, pre-discharg vaccination
- Medical subject headings
- Myocardial Infarction, Arrhythmias, Cardiac, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccinationBiological
Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start12 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Tkaczyszyn, MD, Wroclaw Medical University
- Investigators
- Jan Biegus, Professor, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617376
- Sponsor's protocol ID
- KB 355/2025, KB 171/2026
- Other IDs
- IDUB.E261.24.014, NANO-9/RNZP, SUBD.A460.26.014
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions
- ClinicalTrials.gov ID
- NCT07617376
- Acronym / sponsor ID
- KB 355/2025, KB 171/2026
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Influenza vaccinationpre-discharge influenza vaccine administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccinationInfluenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions | Biological | Influenza vaccination pre-discharge in patients hospitalized for acute cardiac conditions |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Biegus, Professor study chair
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccination in people with Myocardial Infarction and Decompensated Chronic Heart Failure, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Kübler Kübler, Professor (48717364240, piotr.kubler@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection, unplanned cardiovascular hospitalization or cardiovascular death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.