Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions (NCT07617376) | Clinical Trial Compass
RecruitingPhase 4
Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions
Poland400 participantsStarted 2025-11-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is specifically studying flu vaccination given right before hospital discharge after conditions like heart attack, heart failure, or serious arrhythmias, would getting the flu shot at that point actually fit my situation, and is the timing of vaccination during a cardiac hospital stay something my care team thinks is appropriate for me?
2This is a Phase 4 trial, which means the flu vaccine itself is already approved and widely used — so what is my doctor's sense of whether the main question here is really about *when* to give it rather than whether it's safe, and does that change the risk-benefit conversation for me compared to just getting vaccinated at my next doctor's visit?
3The trial is measuring whether pre-discharge vaccination reduces unplanned cardiovascular hospitalizations or cardiovascular death in people with conditions like mine — given my specific diagnosis, does my doctor think the evidence so far suggests I'm someone who could particularly benefit from flu vaccination as part of my cardiac care?
4Would joining this trial affect any other parts of my discharge plan or follow-up care, and are there logistical demands — like specific follow-up visits or data collection — that I should factor into my decision?
5If I decide not to participate in this trial, would my doctor still recommend I get a flu shot before or shortly after discharge as standard care for my cardiac condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
infection, unplanned cardiovascular hospitalization or cardiovascular death