Timing of Influenza Vaccination in Patients With Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Biological: Influenza vaccination administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized in a 1:1 manner to receiving the influenza vaccination during their heart failure hospitalization versus receiving the vaccine during their first follow-up in the heart failure clinic.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-patient vaccination arm<br>Participants in this arm will receive the influenza vaccination during their heart failure hospitalization. | Biological: Influenza vaccination administration<br>* There will be approximately 40 participants who consent; they will be randomized in a 1:1 manner to receiving the influenza vaccination during their heart failure hospitalization versus receiving the vaccine during their first follow-up in the heart failure clinic.<br>|
| Active Comparator: In-clinic vaccination arm<br>Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge. | Biological: Influenza vaccination administration<br>* There will be approximately 40 participants who consent; they will be randomized in a 1:1 manner to receiving the influenza vaccination during their heart failure hospitalization versus receiving the vaccine during their first follow-up in the heart failure clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion for one or more strains in the influenza vaccine one month following vaccination. | Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay. | Randomization to one month post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NTproBNP | Serologic blood work measured at randomization and post-randomization | Randomization to one month post randomization | 
| Change in high-sensitivity troponin | Serologic blood work measured at randomization and post-randomization | Randomization to one month post randomization | 
| Changes in inflammatory markers | Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization | Randomization to one month post randomization |