Life sciences · Interventional Study
ClinicalTrials.gov · October 13, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07721649). This is a study registration, not published results. Lead sponsor: Stephan Baldus. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 482 participants (ESTIMATED). Conditions: Acute Coronary Syndrome, Heart Failure, Influenza, Human, Cardiovascular Diseases, Vaccination Refusal. Interventions: BIOLOGICAL: Intrahospital seasonal influenza vaccination offer; BEHAVIORAL: Standardized active influenza vaccination counseling; BEHAVIORAL: Standard of care discharge recommendation for ambulatory vaccination. Primary outcome measures: Influenza vaccination rate at the end of the index influenza season , From randomization to the end of the index influenza season (March 31), up to approximately 7 months. Brief summary: The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk. Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).