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

Description

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.

Study Start Date

August, 01 2016

Estimated Completion Date

February 2021

Interventions

  • Biological: High Dose Trivalent Influenza Vaccine
  • Biological: Standard Dose Quadrivalent Influenza Vaccine

Study ID

Brigham and Women's Hospital -- 2015P001823

Status

Recruiting

Trial ID

NCT02787044

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

9300

Sponsor

Brigham and Women's Hospital

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-BarrĂ© 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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (18)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Scott D Solomon MD 857-307-1960 ssolomon@bwh.harvard.edu
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
BostonWest Roxbury VA Hospital - West Roxbury, Massachusetts 6.9 miles Jacob Joseph MD None jjoseph16@partners.org
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu
University of Wisconsin - Madison, Wisconsin 933.6 miles Orly Vardeny PharmD MS 608-265-0591 orly.vardeny@wisc.edu

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