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

Completed · Phase 4

Conditions studied: Heart Failure, Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT02787044

Run by

Brigham and Women's Hospital

People needed

5388

Starts

2016-08-01

Expected to finish

2020-05-31

Last updated by the study team

2022-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >= 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama Hypertension Program — Birmingham, Alabama, United States
• Heart Center Research, LLC — Huntsville, Alabama, United States
• Alaska Heart & Vascular Institute — Anchorage, Alaska, United States
• Banner University Medicine North — Tucson, Arizona, United States
• University of Arizona- Sarver Heart Center — Tucson, Arizona, United States
• CAVHS — Little Rock, Arkansas, United States
• VA Loma Linda Healthcare System — Loma Linda, California, United States
• Long Beach VAMC — Long Beach, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• VA West Haven — West Haven, Connecticut, United States
• Washington DC VAMC — Washington D.C., District of Columbia, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• N FL/S GA Veterans Health System — Gainesville, Florida, United States
• OneFlorida CDRN — Gainesville, Florida, United States
• Clearwater Cardiovascular Consultants-Largo — Largo, Florida, United States
• Inpatient Research Corporation — Miami, Florida, United States
• ITB Research — Miami, Florida, United States
• Charlotte Heart Group Research Center — Port Charlotte, Florida, United States
• Clearwater Cardiovascular Consultants-SH — Safety Harbor, Florida, United States
• Bond Community Health Center, Inc. — Tallahassee, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Morehouse School of Medicine — Atlanta, Georgia, United States
• Birmingham VAMC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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