Vaccination Against Influenza Pre-discharge in Patients Hospitalized Due to Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Influenza vaccination
Vaccination pre-discharge in patients stabilized after heart failure exacerbation
干预措施: Influenza vaccination (Biological)
结局指标
主要结局
Primary composite endpoint - cardiovascular death, heart failure hospitalization or infection
时间窗: 6 months
次要结局
未报告次要终点
研究者
Michał Tkaczyszyn, MD
Dr
Wroclaw Medical University