Phase 4
Completed N=5,260
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Source: ClinicalTrials.gov NCT02787044 ↗Enrolled (actual)
5,260
Serious AEs
0.1%
Results posted
Sep 2021
Primary outcomePrimary: All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season — 975; 924 Participant-Seasons — p=0.21
◆ Published Evidence
Highly cited
129citations · ~26 / year
Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial.
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.
Linked Publications (5)
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Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial.
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Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial.
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Stratified proportional win-fractions regression analysis.
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Temporal Association Among Influenza-Like Illness, Cardiovascular Events, and Vaccine Dose in Patients With High-Risk Cardiovascular Disease: Secondary Analysis of a Randomized Clinical Trial.
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Educational Attainment Level and Risk of Mortality and Cardiopulmonary Outcomes in High-Risk Patients With Cardiovascular Disease: The INVESTED Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season |
975; 924 | 0.21 |
| SECONDARY Total Cardiopulmonary Hospitalizations or Death |
1857; 1784 | 0.44 |
| SECONDARY Cardiovascular Death or Hospitalization Within Each Vaccination Season |
805; 752 | 0.16 |
| SECONDARY Death or Cardiopulmonary Hospitalization Across Enrolling Seasons |
955; 918 | 0.26 |
| SECONDARY All-Cause Mortality |
223; 222 | 0.96 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02787044) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.