Heart FailurePhase 4NCT06725927
Vaccination Against Influenza Pre-discharge in Heart Failure
A Phase 4 study testing Influenza vaccination in people with Heart Failure, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
In patients with heart failure (HF), influenza vaccination should be considered to prevent HF hospitalizations. However, vaccination rates among patients with HF are low, in part because of subjective but common concerns about whether patients with such severe disease should be vaccinated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Influenza vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 31 Dec 2024to Dec 2025
- 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
- informed consent to participate in the study
- hospitalization (unplanned) due to exacerbation (decompensation) of heart failure
- planned discharge within the next 48 hours due to completion of hospital treatment
- no current (2024/25 season) influenza vaccination.
Who cannot join
- severe post-vaccination reaction during influenza vaccination in any previous influenza season
- hypersensitivity to any of the components of the vaccine planned to be administered
- discharge to another hospital for continued treatment or discharge to a nursing home
- antibiotic therapy among the drugs recommended for taking after hospitalization.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jan Mikulicz Radecki University Hospital in Wroclaw
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure
In patients with heart failure (HF), influenza vaccination should be considered to prevent HF hospitalizations. However, vaccination rates among patients with HF are low, in part because of subjective but common concerns about whether patients with such severe disease should be vaccinated. In this randomized, open-label study, we will investigate whether influenza vaccination before discharge in patients stabilized after cardiac decompensation is safe and improves outcomes over a 6-month follow-up period.
- Conditions
- Heart Failure
- Being tested
- Influenza vaccination
- Keywords
- heart failure, influenza, vaccination
- Medical subject headings
- Heart Failure, 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 due to heart failure exacerbation
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination | Experimental | Vaccination pre-discharge in patients stabilized after heart failure exacerbation Receives: Biological: Influenza vaccination |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary composite endpoint - cardiovascular death, heart failure hospitalization or 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 posted10 Dec 2024
- Study start31 Dec 2024
- Primary completion30 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 200 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
- NCT06725927
- Sponsor's protocol ID
- KB 659/2024
- Status last verified
- Jul 2025
- First submitted
- 5 Dec 2024
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure
- ClinicalTrials.gov ID
- NCT06725927
- Acronym / sponsor ID
- KB 659/2024
- Conditions
- Heart Failure
- Keywords
- heart failure, influenza, vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2024 (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.
In patients with heart failure (HF), influenza vaccination should be considered to prevent HF hospitalizations. However, vaccination rates among patients with HF are low, in part because of subjective but common concerns about whether patients with such severe disease should be vaccinated. In this randomized, open-label study, we will investigate whether influenza vaccination before discharge in patients stabilized after cardiac decompensation is safe and improves outcomes over a 6-month follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination | Experimental | Biological: Influenza vaccinationVaccination pre-discharge in patients stabilized after heart failure exacerbation |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent to participate in the study
- hospitalization (unplanned) due to exacerbation (decompensation) of heart failure
- planned discharge within the next 48 hours due to completion of hospital treatment
- no current (2024/25 season) influenza vaccination.
Key exclusion criteria (4 listed)
- severe post-vaccination reaction during influenza vaccination in any previous influenza season
- hypersensitivity to any of the components of the vaccine planned to be administered
- discharge to another hospital for continued treatment or discharge to a nursing home
- antibiotic therapy among the drugs recommended for taking after hospitalization.
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 due to heart failure exacerbation | Biological | Influenza vaccination |
Primary outcome
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
Time frame: 6 months
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 23 Jul 2025.
- 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. This study is not recruiting at the moment.
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 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 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection (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 23 Jul 2025.