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

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ClinicalTrials.gov Identifier: NCT02787044
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
University of Toronto
Boston VA Research Institute, Inc.
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Scott David Solomon, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Myocardial Infarction Biological: High Dose Trivalent Influenza Vaccine Biological: Standard Dose Quadrivalent Influenza Vaccine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Dose Influenza Vaccine
High Dose Influenza Vaccine
Biological: High Dose Trivalent Influenza Vaccine
High Dose Trivalent Influenza Vaccine

Active Comparator: Standard Dose Influenza Vaccine
Standard Dose Influenza Vaccine
Biological: Standard Dose Quadrivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine




Primary Outcome Measures :
  1. All-Cause Death or Cardiopulmonary Hospitalization [ Time Frame: Up to 3 years ]
    Tme to first occurrence of death or cardiopulmonary hospitalization


Secondary Outcome Measures :
  1. Total cardiopulmonary hospitalizations or death [ Time Frame: Up to 3 years ]
    Total (first and recurrent) cardiopulmonary hospitalizations or death

  2. Death or cardiopulmonary hospitalization within each influenza season [ Time Frame: Up to one year from randomization ]
    Time to first occurrence of cardiovascular death or cardiovascular hospitalization within each influenza season

  3. Death or cardiopulmonary hospitalizations across all influenza seasons [ Time Frame: Up to three years ]
    Death or cardiopulmonary hospitalization across all enrolled influenza seasons

  4. All-Cause Mortality [ Time Frame: Up to 3 years ]
    Time to first occurrence of all-cause mortality

  5. Cardiopulmonary Hospitalization [ Time Frame: Up to 3 years ]
    Time to first occurrence of cardiopulmonary hospitalization

  6. Number of participants with treatment-related adverse events [ Time Frame: Up to 3 years ]
    Number of participants with treatment-related adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787044


Contacts
Contact: Orly Vardeny, PharmD, MS 6124674586 ovardeny@umn.edu
Contact: Jay Udell, MD 416-351-3732 ext 2459 jay.udell@utoronto.ca

  Show 190 Study Locations
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
University of Toronto
Boston VA Research Institute, Inc.
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Orly Vardeny, PharmD, MS University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Scott D Solomon, MD Brigham and Women's Hospital
Principal Investigator: KyungMann Kim, PhD University of Wisconsin, Madison

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Scott David Solomon, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02787044     History of Changes
Other Study ID Numbers: 2015P001823
U01HL130163 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared according to NIH data sharing rules

Keywords provided by Scott David Solomon, Brigham and Women's Hospital:
influenza vaccine
cardiopulmonary hospitalization
heart failure
myocardial infarction
clinical trial

Additional relevant MeSH terms:
Heart Failure
Influenza, Human
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs