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

Research area:
Heart Failure
Principal investigator:
Peter A. McCullough, MD, MPH, FACC, FACP, FAHA, FCCP, FNKF, FNLA, FCRSA
Type of study:
Interventional

Study synopsis:
A substantial number of individuals in North America with myocardial infarction or heart failure (HF) are at high risk for influenza infection and associated morbidity, mortality and increased health care costs despite annual influenza vaccination. A higher dose of vaccine is approved for use in older adults but not in patients with heart failure. Antibody-mediated immunity contributes to vaccine-induced protection from influenza illness. This multi-center, double blinded randomized trial will be conducted with patients assigned to the standard dose vaccine and patients assigned a high dose influenza vaccine. The primary outcome measure is the composite of death or cardiopulmonary hospitalization, assessed at the end of each influenza season. Secondary outcomes will include the composite of death or cardiovascular hospitalizations, death or all-cause hospitalizations, and mortality. The study will also examine associations between geometric mean antibody titers and risk for death or cardiopulmonary hospitalizations.

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

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at: https://www.clinicaltrials.gov/ct2/show/NCT02787044?term=INVESTED&rank=1
Study contact:
Laura Clariday, Laura.Clariday@BSWHealth.org, 214.820.7224.

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