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临床试验/NCT05507502
NCT05507502Unknown不适用

Optimizing the Timing of Influenza Vaccination in Patients With Heart Failure: the FLU-HF Randomized Trial: a Randomized Controlled Trial

Abhinav Sharma1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Seroconversion for one or more strains in the influenza vaccine one month following vaccination.

研究概览

简要总结

Heart failure (HF) is one of the most common causes of hospital admission in Canada and costs the Canadian healthcare system over $1 billion annually. Influenza vaccination is an inexpensive strategy to prevent influenza infections and reduce an important trigger for HF decompensation and hospital readmission. Yet, the optimal timing of vaccine administration remains unclear. When patients with HF are admitted to the hospital with an acute decompensation in advance of, or during, the 'flu season', this can be an ideal time to administer the vaccine. However, patients with acute HF decompensation have significant inflammatory injury, and may have substantially impaired immune responses; thus vaccine administration while admitted during an acute decompensated HF episode may not lead to high anti-influenza antibody titres. A more effective strategy can be to vaccinate after the decompensation has resolved, when patients are more stable. The FLU-HF randomized trial will determine whether administering the influenza vaccine to patients admitted in-hospital with an acute HF decompensation or waiting until they have stabilized as an out-patient leads to an improved anti-influenza response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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 > 18 years
  • •Admitted in hospital with primary diagnosis of acute HF
  • •Prior diagnosis of chronic HF > 3 months prior to admission
  • •Not on inotropes, mechanical support, or IV diuretics for 24 hours
  • •Able to follow-up within the MUHC HF clinic as per schedule
  • •agree to receive influenza vaccination

排除标准

  • •Any person who does not meet the above criteria and/or who refuses to participate
  • •Already received this seasons influenza vaccination
  • •Known allergy to influenza vaccination or components of the influenza vaccination
  • •Unlikely to survive to discharge as per admitting physician
  • •Prior organ transplant
  • •Undergoing chemotherapy for active malignancy
  • •Currently randomized in another clinical study

研究组 & 干预措施

In-patient vaccination arm

Active Comparator

Participants in this arm will receive the influenza vaccination during their heart failure hospitalization.

干预措施: Influenza vaccination administration (Biological)

In-clinic vaccination arm

Active Comparator

Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge.

干预措施: Influenza vaccination administration (Biological)

结局指标

主要结局

Seroconversion for one or more strains in the influenza vaccine one month following vaccination.

时间窗: Randomization to one month post randomization

Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.

次要结局

  • Change in NTproBNP(Randomization to one month post randomization)
  • Change in high-sensitivity troponin(Randomization to one month post randomization)
  • Changes in inflammatory markers(Randomization to one month post randomization)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abhinav Sharma

Assistant Professor, Division of Cardiology

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (1)

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