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Trial record 1 of 1 for:    NCT02787044
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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 : Completed
First Posted : June 1, 2016
Results First Posted : September 14, 2021
Last Update Posted : January 21, 2022
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
University of Minnesota
Information provided by (Responsible Party):
Scott David Solomon, Brigham and Women's Hospital

Study Description
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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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5388 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
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season [ Time Frame: Up to 1 year from vaccination (repeats seasonally) ]
    Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season


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

  2. Cardiovascular Death or Hospitalization Within Each Vaccination Season [ Time Frame: Up to one year from vaccination ]
    Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season

  3. Death or Cardiopulmonary Hospitalization Across Enrolling Seasons [ Time Frame: Up to three years ]
    First cardiopulmonary Hospitalization or all-cause death across enrolling seasons

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


Eligibility Criteria
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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
    • 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.
Contacts and Locations
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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


Locations
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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
University of Minnesota
Investigators
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Principal Investigator: Orly Vardeny, PharmD, MS University of Minnesota
Principal Investigator: Scott D Solomon, MD Brigham and Women's Hospital
Principal Investigator: KyungMann Kim, PhD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by Scott David Solomon, Brigham and Women's Hospital:
Study Protocol  [PDF] July 23, 2019
Statistical Analysis Plan  [PDF] July 31, 2020
Informed Consent Form  [PDF] July 30, 2019

More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Scott David Solomon, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02787044    
Other Study ID Numbers: 2015P001823
U01HL130163 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2016    Key Record Dates
Results First Posted: September 14, 2021
Last Update Posted: January 21, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared according to NIH data sharing rules
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available as per NIH guidelines on December 4, 2022 (2 years from the primary study publication date).
Access Criteria: Data will be available to all qualified researchers based on the NIH BIOLINCC criteria.
URL: https://biolincc.nhlbi.nih.gov/home/
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:
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Influenza, Human
Heart Failure
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs