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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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
- 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
Participation in an investigational drug study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Paul McKie, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul McKie, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials