Study Type
Interventional - Drug
The objective of the IVVE study is 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.
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.
Primary endpoint:
A composite of major adverse vascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
This is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals.
The Principal Investigator of the IVVE study is Mark Loeb, Division Director, Infectious Diseases, McMaster University.
Interventional - Drug
Multi-centre, placebo RCT
10
30
5139
2015-2021
PHRI
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