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IVVE

Official Title

A Randomized Trial of Influenza Vaccine to Prevent Adverse Vascular Events

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. 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.

Study Design

Randomized, multicenter, placebo controlled, pilot trial.

Primary Endpoint

A composite of major adverse vascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.

Number of Patients

5000

Number of Sites

36

Number of Countries

11

Study Period

2014–2022

Principal Investigator

Mark Loeb, Hisham Dokainish

Program Manager

Tara McCready

Research Coordinator

Alex Grinvalds

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