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Research

Photo for IVVE

IVVE

Official Title

A Randomized Trial of Influenza Vaccine to Prevent Adverse Vascular Events: A Pilot Study

Status

Ongoing

Overview

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

Study Design

Randomized, multicenter, placebo controlled, pilot trial.

Primary Endpoint

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

Number of Patients

600

Number of Sites

15

Number of Countries

15

Study Period

2014–2015

Principal Investigator

Mark Loeb, Hisham Dokainish

Program Manager

Kimberly Begley

Research Coordinator

Alex Grinvalds