Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT02787044

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure

Official Title:

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure

Summary

INVESTED will 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. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

Eligibility

Inclusion Criteria:

* >= 18 years of age
* history of hospitalization for myocardial infarction within 1 year of enrollment OR a history of hospitalization for heart failure within 2 years of enrollment
* At least one of the following additional risk factors:

* Prior MI (if HF the index event above; or a second MI)
* Prior HF hospitalization (if MI the index event above; or a second HF event)
* Age ≥ 65
* Left ventricular ejection fraction (LVEF) < 40%
* Diabetes mellitus
* Obesity (BMI ≥ 30)
* Renal impairment (eGFR ≤ 60)
* History of ischemic stroke
* History of peripheral artery disease
* Current smoking

Exclusion Criteria:

* Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6 weeks after influenza vaccine
* Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months.
* Receipt of influenza vaccine during current influenza season
* Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.
* Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.

Disease(s) and\or Condition(s)

Heart Failure

Myocardial Infarction

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: High Dose Trivalent Influenza Vaccine
    • Description: High Dose Trivalent Influenza Vaccine
    • Arm Group Labels: High Dose Influenza Vaccine
    • Type: BIOLOGICAL
    • Name: Standard Dose Quadrivalent Influenza Vaccine
    • Description: Standard Dose Quadrivalent Influenza Vaccine
    • Arm Group Labels: Standard Dose Influenza Vaccine
Sponsor
  • Brigham and Women's Hospital