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Bedside flu shot for heart patients: a simple strategy to save lives?

NCT ID NCT07721649

Prevention Sponsor: Stephan Baldus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether offering a seasonal flu vaccine to heart patients while they are still in the hospital, along with active counseling, increases vaccination rates compared to counseling alone. The study enrolls adults hospitalized for acute coronary syndrome or heart failure who are eligible for the flu shot. The goal is to see if bedside vaccination can overcome common barriers like forgetfulness or access issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
seasonal influenza vaccine (high-dose or standard-dose)
What this could lead to
If it works, this approach could significantly increase flu vaccination rates among high-risk heart patients, potentially preventing serious flu-related complications.
What could go wrong
This is a single-country trial with 482 participants, so results may not apply everywhere. The intervention may not change long-term vaccination behavior beyond the first season.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 482 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 years or older * Hospitalized due to acute coronary syndrome (ACS) or congestive heart failure (CHF) and fulfilling the criteria for influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) * Written informed consent Exclusion Criteria: * Already received seasonal influenza vaccination in the current season, based on self-reported vaccination status and/or vaccination certificate * Laboratory-confirmed active influenza infection during the index hospitalization * Contraindication for vaccination (e.g., known allergy) * Inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome cardiovascular disorder congestive heart failure heart failure Vaccination Hesitancy Vaccination Refusal influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome Cardiovascular diseases Heart failure Influenza, human Vaccination refusal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinic III for Internal Medicine, University Hospital of Cologne

    Cologne, 50937, Germany

  • Department of Cardiology, University Heart and Vascular Centre Hamburg

    Hamburg, 20246, Germany

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