Study Type
Interventional - Drug
ongoing
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.
Study Design
Multi-centre, placebo RCT
NO. of Countries
10
NO. of Sites
30
NO. of Participants
5139
Study Period
2015-2021
Sponsor
PHRI
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
