Influenza Vaccine To Prevent Adverse Vascular Events:Pilot — IVVE:Pilot  

Heart Failure Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Influenza, Human

• NCT number: NCT01945268
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Completion date: December 2015