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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

More information

Publications

  • Influenza leads to significant cardiopulmonary morbidity and mortality-particularly in patients with cardiovascular disease-that may be prevented with a standard influenza vaccine. However, patients with cardiovascular conditions have a reduced immune response to influenza vaccine, potentially resulting in reduced effectiveness for preventing clinical events. High-dose vaccine augments immune response in cardiac patients, suggesting that a high-dose influenza vaccination strategy may further reduce morbidity and mortality. Alternatively, broader coverage with an influenza vaccine containing an increased number of viral strains is an alternative strategy without direct evaluation. Read More on PubMed
  • This study sought to examine the prevalence and predictors of influenza vaccination among participants in the PARADIGM-HF (Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) study and investigate associations between receiving influenza vaccine and cardiovascular death or heart failure hospitalizations, all-cause hospitalizations, and cardiopulmonary or influenza-related hospitalizations. Read More on PubMed
  • Each year, influenza infection is responsible for substantial morbidity and mortality across the globe. Because confirmatory testing is often not performed, the total burden of influenza on annual cardiopulmonary (respiratory and cardiac) hospitalizations is likely even higher. Read More on PubMed
  • Patients with heart failure (HF) have lower initial antibody responses to the influenza vaccine compared with healthy individuals. Whether antibody titers wane faster in this population remains unknown. Read More on PubMed
  • Among nontraditional cardiovascular risk factors, recent influenzalike infection is associated with fatal and nonfatal atherothrombotic events. Read More on PubMed
  • Influenza infection leads to increased morbidity and mortality in those with heart failure, and individuals with heart failure exhibit reduced antibody responses to influenza vaccine. We hypothesized that patients with heart failure randomized to double dose (DD) influenza vaccine will mount more vigorous humoral immune responses compared with those given standard dose (SD) vaccine. Read More on PubMed
  • To determine whether T-cell immune responses to influenza vaccination in patients with chronic heart failure (CHF) are less vigorous than the responses of healthy control subjects. Read More on PubMed
  • Heart failure (HF) patients are at risk for influenza despite widespread vaccination. Both humoral (antibody) and cytotoxic T-lymphocyte (CTL) responses are important for protection. We explored antibody- and CTL-mediated responses to the influenza vaccine in HF patients compared with healthy controls. Read More on PubMed

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CLS-20349206

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