Study on the Impact of Coordinated Immunizations Against RSV and Influenza on the Prognosis in Patients With Chronic Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Composite endpoint: All-cause mortality, hospitalization due to heart failure, and the clinical signs of infection, characterized by a body temperature exceeding 38 degrees Celsius.
研究概览
简要总结
This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure.
The main question it aims to answer is:
• Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?
详细描述
The study aims to determine whether coordinated care in the form of administering protective vaccinations affects the prognosis of patients with chronic heart failure. The study will involve analyzing epidemiological data for each participant, followed by randomization into two treatment paths: receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) versus following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). All vaccinations will be administered using vaccines registered with the appropriate authorities and approved for use in the EU and Poland.
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
- •Age above 18 years
- •Willingness to provide informed consent for participation in the study
- •Diagnosis of heart failure
- •No previous vaccination against RSV or influenza
排除标准
- •History of an anaphylactic reaction to vaccination
- •Hypersensitivity to any component of the vaccine
- •Receipt of vaccination against RSV or influenza in the current infectious
- •Active infection
- •Pregnancy
结局指标
主要结局
Composite endpoint: All-cause mortality, hospitalization due to heart failure, and the clinical signs of infection, characterized by a body temperature exceeding 38 degrees Celsius.
时间窗: 180 days
Number of days from the intervention to the occurrence of the composite endpoint.
次要结局
未报告次要终点
研究者
Jan Biegus, MD, PhD
MD, PhD
Wroclaw Medical University