Vaccination Against Influenza Pre-discharge in Heart Failure

Phase 4

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Biological: Influenza vaccination

• Registration Number: NCT06725927
• Lead Sponsor: Wroclaw Medical University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2024-12-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-18
• Last Update Posted: 2025-07-23
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza vaccination	Influenza vaccination	Vaccination pre-discharge in patients stabilized after heart failure exacerbation

Primary Outcome Measures

Name	Time	Method
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection	6 months

Trial Locations

Locations (1)

Jan Mikulicz Radecki University Hospital in Wroclaw; 🇵🇱 Wrocław, Dolnoslaskie, Poland