CompletedPhase 4

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

United States, Canada, Puerto Rico5,388 participantsStarted 2016-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season

Timeframe: Up to 1 year from vaccination (repeats seasonally)

Trial details

NCT IDNCT02787044

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-31

Results submitted2021-05-24

View on ClinicalTrials.gov More Heart Failure trials