Vaccination Against Influenza Pre-discharge in Heart Failure

Wroclaw Medical University

Status and phase: Active, not recruiting; Phase 4

Conditions: Heart Failure

Treatments: Biological: Influenza vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT06725927

KB 659/2024

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Influenza vaccination

Experimental group

Description:

Vaccination pre-discharge in patients stabilized after heart failure exacerbation

Treatment:

Biological: Influenza vaccination

Standard of care

No Intervention group