Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787044
Recruitment Status : Active, not recruiting
First Posted : June 1, 2016
Last Update Posted : October 9, 2019
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

Layout table for study information
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
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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Birmingham VAMC
Birmingham, Alabama, United States, 35233
University of Alabama Hypertension Program
Birmingham, Alabama, United States, 35294
Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
United States, Alaska
Alaska Heart & Vascular Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Banner University Medicine North
Tucson, Arizona, United States, 85719
University of Arizona- Sarver Heart Center
Tucson, Arizona, United States, 85724
United States, Arkansas
CAVHS
Little Rock, Arkansas, United States, 72205
United States, California
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Long Beach VAMC
Long Beach, California, United States, 90822
University of California Davis Medical Center
Sacramento, California, United States, 95817
VA San Diego Healthcare System
San Diego, California, United States, 92161
UCSF Medical Center
San Francisco, California, United States, 94143
United States, Connecticut
VA West Haven
West Haven, Connecticut, United States, 06516
United States, District of Columbia
Washington DC VAMC
Washington, District of Columbia, United States, 20422
United States, Florida
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
N FL/S GA Veterans Health System
Gainesville, Florida, United States, 32608
OneFlorida CDRN
Gainesville, Florida, United States, 32611
Clearwater Cardiovascular Consultants-Largo
Largo, Florida, United States, 33777
Inpatient Research Corporation
Miami, Florida, United States, 33014
ITB Research
Miami, Florida, United States, 33173
Charlotte Heart Group Research Center
Port Charlotte, Florida, United States, 33952
Clearwater Cardiovascular Consultants-SH
Safety Harbor, Florida, United States, 34695
Bond Community Health Center, Inc.
Tallahassee, Florida, United States, 32301
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Atlanta VA Health Care System
Decatur, Georgia, United States, 30033
Peidmont Fayette
Fayetteville, Georgia, United States, 30214
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Chicago Medical Research
Hazel Crest, Illinois, United States, 60429
Northwester Medicine Lake Forest
Lake Forest, Illinois, United States, 60045
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, United States, 60064
UnityPoint Health Methodist
Peoria, Illinois, United States, 61606
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
Krannert Institute of Cardiology
Indianapolis, Indiana, United States, 46202
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
VA Eastern Kansas Health Care System
Leavenworth, Kansas, United States, 66048
United States, Kentucky
Robley Rex VA
Louisville, Kentucky, United States, 40206
United States, Louisiana
The Heart Clinic of Hamond
Hammond, Louisiana, United States, 70403
Southeast Louisiana Veterans Healthcare System
New Orleans, Louisiana, United States, 70112
Ochsner Health System- Baton Rouge
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
ENRM VA Hospital
Bedford, Massachusetts, United States, 01730
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
Charles River Medical Associates
Natick, Massachusetts, United States, 01760
Boston/West Roxbury VA Hospital
West Roxbury, Massachusetts, United States, 02132
VA Boston Healthcase System
West Roxbury, Massachusetts, United States, 02132
United States, Michigan
VA Ann Harbor Healthcare System
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
HealthPartners - Riverside Research
Minneapolis, Minnesota, United States, 55454
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
HealthEast Medical Research Institute
Saint Paul, Minnesota, United States, 55102
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
VA St. Louis Health Care System
Saint Louis, Missouri, United States, 63106
St. Louis University
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Heart Institute- Grand Island
Grand Island, Nebraska, United States, 68803
United States, New Hampshire
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cardio Assoc. of the Del. Valley- Elmer
Elmer, New Jersey, United States, 08318
Cardio. Assoc. of the Del. Valley- Haddon Heights
Haddon Heights, New Jersey, United States, 08035
Cardio. Assoc. of the Del. Valley- Sewell
Sewell, New Jersey, United States, 08080
Lourdes Cardiology Services
Voorhees, New Jersey, United States, 08043
United States, New Mexico
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108
United States, New York
Albany Medical College
Albany, New York, United States, 12208
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
New York Presbyterian Queens Bayside/Whitestone
Flushing, New York, United States, 11355
New York Presbyterian/Queens
Flushing, New York, United States, 11355
NYPQ - Cardiology Outpatient Clinic
Flushing, New York, United States, 11355
Winthrop University Hospital
Mineola, New York, United States, 11501
New York VA
New York, New York, United States, 10010
NYU Langone Medical Center
New York, New York, United States, 10016
New York Presbyterian
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
Charles George VA
Asheville, North Carolina, United States, 28805
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke
Durham, North Carolina, United States, 27710
United States, Ohio
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
Heart House Research Foundation
Springfield, Ohio, United States, 45504
United States, Oregon
Oregon Health & Science
Portland, Oregon, United States, 97239
VA Portland Health Care Systems (VAPHCS)
Portland, Oregon, United States, 97239
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
WJB Dorn VAMC
Columbia, South Carolina, United States, 29209
Palmetto Research Center, LLC
Spartanburg, South Carolina, United States, 29302
United States, Tennessee
VAMC Memphis
Memphis, Tennessee, United States, 38104
Meharry Medical College
Nashville, Tennessee, United States, 37208
Tennessee Valley Healthcare Systems-Nashville
Nashville, Tennessee, United States, 37212
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Heart- Heart Hospital
Austin, Texas, United States, 78756
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, United States, 75226
Michael E. DeBakey VAMC, Houston
Houston, Texas, United States, 77030
Houston Heart & Vascular Associates
Kingwood, Texas, United States, 77339
Houston Methodist Research Institute-CCAT Pearland
Pearland, Texas, United States, 77584
St. David's Heath & Vascular PLLC
Round Rock, Texas, United States, 78681
South Texas Veterans Healthcare System
San Antonio, Texas, United States, 78229
STAR Clinical Trials
San Antonio, Texas, United States, 78229
Austin Heart San Marcos
San Marcos, Texas, United States, 78666
Baylor Scott and White Research Institute
Temple, Texas, United States, 76508
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
George E. Wahlen Dept of VA Affairs Medical Center
Salt Lake City, Utah, United States, 84148
United States, Vermont
VA Medical Center White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Inova Heart and Vascular Institute
Alexandria, Virginia, United States, 22306
Carient Heart & Vascular
Manassas, Virginia, United States, 20109
United States, West Virginia
Louis A Johnson VAMC
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
Gundersen Clinic
La Crosse, Wisconsin, United States, 54601
University of Wisconsin
Madison, Wisconsin, United States, 53705
Willam S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
University of Wisconsin Madison
Madison, Wisconsin, United States, 57305
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora Research Institute, LLC
Milwaukee, Wisconsin, United States, 53233
Celement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Canada, Alberta
TotalCardiology
Calgary, Alberta, Canada, T2E 7C5
University of Calgary
Calgary, Alberta, Canada, T2N4Z6
CK Hui Heart Centre, Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H3V9
Dr. MPJ Senaratne Professional Corporation
Edmonton, Alberta, Canada, T6K4C1
Northwest Echocardiolography
Grande Prairie, Alberta, Canada, T8V 2E7
The CARe Clinic (Central Alberta Research)
Red Deer, Alberta, Canada, T4N6V7
Canada, British Columbia
University of Alberta Hospital- Mazankoski Heart Institute
Edmonton, British Columbia, Canada, T6G2B7
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y1T2
SMH Cardiology Clinical
Surrey, British Columbia, Canada, V3V 0C6
Manna Research Inc. (Vancouver)
Vancouver, British Columbia, Canada, V5X0C4
Vancouver General Hospital - Gordon Leslie Diamond Centre
Vancouver, British Columbia, Canada, V5Z1M9
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R4R2
Canada, Manitoba
St. Boniface Hospital/University of Manitoba
Winnipeg, Manitoba, Canada, R2H2A6
Canada, New Brunswick
University of Sherbrooke
Dieppe, New Brunswick, Canada
G.A Research Associates Ltd.
Moncton, New Brunswick, Canada, E1G 1A7
Canada, Nova Scotia
QEII Health Sciences
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Brampton Research Assocaites
Brampton, Ontario, Canada, L6Z 4N5
Manna Research Inc. (Burlington North)
Burlington, Ontario, Canada, L7M 4Y1
Manna Research Inc. (Burlington South)
Burlington, Ontario, Canada, L7R 1A4
Cambridge Cardiac Care Center
Cambridge, Ontario, Canada, N1R 6V6
Vizel Cardiac Research
Cambridge, Ontario, Canada, N1R 7R1
Dr. Alan David Bell
Downsview, Ontario, Canada, M3M 3E5
Hamilton Health Sciences General Hospital/ McMaste
Hamilton, Ontario, Canada, L8L 2X2
Queen's University CardioPulmonary Unit
Kingston, Ontario, Canada, K7L 3N6
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Dixie Medical Group
Mississauga, Ontario, Canada, L4W 0C2
Apple Hills Medical Associates
Mississauga, Ontario, Canada, L4Y 2N8
PACE
Newmarket, Ontario, Canada, L3Y 2P6
North York General Hospital
North York, Ontario, Canada, M2K 1E1
Sewa Ram Singal Med Prof Corporation
North York, Ontario, Canada, M3N 1N1
Heart Care Research
Oshawa, Ontario, Canada, L1J 2J9
Dr. James Cha
Oshawa, Ontario, Canada, L1J 2K1
Montfort Hospital and Ottawa Cardiovascular Centre
Ottawa, Ontario, Canada, K1K 0T2
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Heart Function Clinic Queensway Carleton
Ottawa, Ontario, Canada, K2H 8P4
Kawartha Cardiology
Peterborough, Ontario, Canada, K9J0B2
Scarborough General Hospital
Scarborough, Ontario, Canada, M1P 2T7
St. Catherines Hospital
St. Catherines, Ontario, Canada, L2M 5V4
Manna Research (Stoney Creek)
Stoney Creek, Ontario, Canada, L8J 3W2
Health Sciences North Research Institute
Sudbury, Ontario, Canada, P3E 5J1
Dr. D. Shukla Professional Medicine Corporation
Sudbury, Ontario, Canada, P3E 5M4
Dr. R. Labonte Professional Medicine Corporation
Sudbury, Ontario, Canada, P3E 5M4
Thunder Bay Regional Health Sciences Center
Thunder Bay, Ontario, Canada, P7B 6V4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
University of Toronto
Toronto, Ontario, Canada
iHealthCentre
Vaughan, Ontario, Canada, L4H 0P6
Canada, Quebec
CISSS de Laval, Hopital Cite de la Sante
Laval, Quebec, Canada, H7M 3L9
Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
McGill University Health Centre
Montréal, Quebec, Canada, H3G 1A4
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
CIUSSS NÎM Hopital du Sacre-Coeur de Montreal
Montréal, Quebec, Canada, H4J 1C5
Manna Research Inc. (Montreal)
Montréal, Quebec, Canada, H9R 4S3
IUCPQ
Quebec City, Quebec, Canada, G1V 4G5
Centre hospitalier régional de Lanaudière
St-Charles Borromee, Quebec, Canada, J6E 6J2
CISSSI- Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada, J6V 2H2
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivières, Quebec, Canada, G8Z 3R9
Canada, Saskatchewan
Prairie Vascular Research Inc.
Regina, Saskatchewan, Canada, 54P 0W5
Puerto Rico
VA Caribbean Healthcare System
San Juan, Puerto Rico, 00921
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
Layout table for investigator information
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

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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: October 9, 2019
Last Verified: October 2019
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:
Layout table for MeSH terms
Influenza, Human
Heart Failure
Myocardial Infarction
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