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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-patient vaccination arm | Active Comparator | Participants in this arm will receive the influenza vaccination during their heart failure hospitalization. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccination administration | Biological | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination. | Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay. | Randomization to three months post randomization |
| Change in NTproBNP |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Moawad, MSc. | Contact | (514) 934-1934 | 35414 | dina.moawad@muhc.mcgill.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| 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 |
Serologic blood work measured at randomization and post-randomization |
| Randomization to three months post randomization |
| Change in high-sensitivity troponin | Serologic blood work measured at randomization and post-randomization | Randomization to three months post randomization |
| Changes in inflammatory markers | Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization | Randomization to three months post randomization |