Heart Failure
Conditions
Keywords
vascular, influenza, vaccine, heart failure
Brief summary
A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.
Detailed description
Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.
Interventions
0.5 ml dose injected intramuscularly
OTHERSterile saline
0.5 ml dose injected intramuscularly
Sponsors
Population Health Research Institute
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and NYHA functional class II, III and IV
Exclusion criteria
* Anaphylactic reaction to a previous dose of TIV * Known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock * Guillain-Barré syndrome within eight weeks of a previous influenza vaccine * Anaphylactic reaction to neomycin * Patients who have had influenza vaccine in two of the three previous years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | Six months | If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse cardiovascular event | Six months | The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. |
| Cardiovascular death | Six months | CV death alone will be a secondary outcome. |
Countries
Mozambique, Philippines, Uganda
Outcome results
None listed