Kyungmann Kim

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INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)-Data Coordinating Center

Influenza infection is known to be associated with increased risk of cardiovascular events, and leads to significant morbidity and mortality each year. Annual influenza vaccination is recommended by the Centers for Disease Control and Prevention, but the optimal vaccine regimen that portends the most protection in patients with high risk cardiovascular disease is unclear. The INVESTED study is a multi-center, randomized, active- control clinical trial of high dose influenza vaccine compared to standard dose influenza vaccine for three seasons in adult individuals with a history of myocardial infarction or heart failure who are at high risk for cardiovascular events. The primary outcome is time to first occurrence of death or cardiopulmonary hospitalization, and key secondary outcomes include time to occurrence of the cardiopulmonary death or cardiopulmonary hospitalizations, time to occurrence of all-cause death or all-cause hospitalizations, time to occurrence of all-cause death or cardiovascular hospitalizations, cardiopulmonary death, and all-cause death. The association between geometric mean antibody titers with the risk for death or cardiopulmonary hospitalizations will also be investigated. The results of this trial have the potential to inform health care policy regarding optimal influenza vaccination for individuals with high risk cardiovascular disease, which may in turn reduce morbidity from this annual threat to health stability in patients with cardiovascular conditions. (End of Abstract)