Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED)

Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED)

Lead Principal Investigator: Scott Solomon, MD and Orly Vardeny, PharmD

Organization:  Harvard Medical School and University of Wisconsin-Madison

Purpose:  To test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.

Funded by the National Heart, Lung, and Blood Institute, ClinicalTrials.gov NCT02787044

Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED)

Lead Principal Investigator: Scott Solomon, MD and Orly Vardeny, PharmD

Organization:  Harvard Medical School and University of Wisconsin-Madison

Purpose:  To test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure.

Funded by the National Heart, Lung, and Blood Institute, ClinicalTrials.gov NCT02787044

Overview

sites

Enrolled 494 participants from 39 sites since September 21, 2016
Completed Vanguard year
Currently enrolling additional sites for second year

who's involved?

sites

7 participating Networks:
GPC, LHSnet, Mid-South CDRN, OneFlorida, PaTH, REACHnet, SCILHS
8 VA hospitals
4 Canadian sites
14 additional medical centers around the U.S.

hospital

how we're making a difference

First example of using SMART IRB for an NIH-funded multisite clinical trial
First trial to study high dose vaccine in high–risk cardiac patients with relation to cardiopulmonary outcomes
In contrast to more complex interventions in patients with cardiac disease, the major potential benefits of this intervention are the ease of administration, low cost, 100% vaccination adherence, and well established and extremely low risks