A Randomized Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study
To assess the feasibility of randomizing heart failure (HF) patients to either inactivated influenza vaccine or to placebo to assess whether influenza vaccine can reduce adverse vascular events in this population. The primary outcome for the eventual trial will be a composite of major adverse vascular events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Demonstration of influenza vaccine leading to a reduction in major adverse vascular events in HF patients would lead to a major change in how these patients are managed. Given the large burden of HF in Canada and globally, the possibility to reduce major vascular events is a compelling reason to conduct this pilot which will lay the groundwork for the eventual trial
Randomized, multicenter, placebo controlled, pilot trial.
Pilot study endpoint – to see whether it is feasible to randomize patients to influenza vaccine or saline placebo vaccine over the course of one influenza season. Composite outcome events will include cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for heart failure
Mark Loeb, Hisham Dokainish