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

Primary Purpose

Heart Failure, Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
High Dose Trivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring influenza vaccine, cardiopulmonary hospitalization, heart failure, myocardial infarction, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham VAMC
  • University of Alabama Hypertension Program
  • Heart Center Research, LLC
  • Alaska Heart & Vascular Institute
  • Banner University Medicine North
  • University of Arizona- Sarver Heart Center
  • CAVHS
  • VA Loma Linda Healthcare System
  • Long Beach VAMC
  • University of California Davis Medical Center
  • VA San Diego Healthcare System
  • UCSF Medical Center
  • VA West Haven
  • Washington DC VAMC
  • Clearwater Cardiovascular Consultants
  • N FL/S GA Veterans Health System
  • OneFlorida CDRN
  • Clearwater Cardiovascular Consultants-Largo
  • Inpatient Research Corporation
  • ITB Research
  • Charlotte Heart Group Research Center
  • Clearwater Cardiovascular Consultants-SH
  • Bond Community Health Center, Inc.
  • Piedmont Heart Institute
  • Morehouse School of Medicine
  • Atlanta VA Health Care System
  • Peidmont Fayette
  • University of Hawaii
  • Northwestern University
  • Jesse Brown VA Medical Center
  • University of Chicago Medicine
  • Chicago Medical Research
  • Northwester Medicine Lake Forest
  • Loyola University Medical Center
  • Captain James A. Lovell Federal Health Care Center
  • UnityPoint Health Methodist
  • Central DuPage Hospital
  • Krannert Institute of Cardiology
  • St. Vincent Medical Group
  • University of Iowa
  • The University of Kansas Medical Center
  • VA Eastern Kansas Health Care System
  • Robley Rex VA
  • The Heart Clinic of Hamond
  • Southeast Louisiana Veterans Healthcare System
  • Ochsner Health System- Baton Rouge
  • ENRM VA Hospital
  • Brigham and Women's Hospital
  • Brigham and Women's Faulkner Hospital
  • Beth Israel Deaconess Medical Center
  • Pentucket Medical Associates
  • Charles River Medical Associates
  • Boston/West Roxbury VA Hospital
  • VA Boston Healthcase System
  • VA Ann Harbor Healthcare System
  • Abbott Northwestern Hospital
  • HealthPartners - Riverside Research
  • University of Minnesota
  • Mayo Clinic
  • HealthEast Medical Research Institute
  • University of Mississippi Medical Center
  • Kansas City VA Medical Center
  • VA St. Louis Health Care System
  • St. Louis University
  • Washington University School of Medicine
  • Nebraska Heart Institute- Grand Island
  • Darthmouth-Hitchcock Medical Center
  • Cardio Assoc. of the Del. Valley- Elmer
  • Cardio. Assoc. of the Del. Valley- Haddon Heights
  • Cardio. Assoc. of the Del. Valley- Sewell
  • Lourdes Cardiology Services
  • New Mexico VA Health Care System
  • Albany Medical College
  • New York Presbyterian Brooklyn Methodist Hospital
  • New York Presbyterian Queens Bayside/Whitestone
  • New York Presbyterian/Queens
  • NYPQ - Cardiology Outpatient Clinic
  • Winthrop University Hospital
  • New York VA
  • NYU Langone Medical Center
  • New York Presbyterian
  • Columbia University Medical Center
  • University of Rochester Medical Center
  • Stony Brook University Hospital
  • Charles George VA
  • University of North Carolina at Chapel Hill
  • Duke
  • Louis Stokes Cleveland VA Medical Center
  • Cleveland Clinic
  • Ohio State University
  • Heart House Research Foundation
  • Oregon Health & Science
  • VA Portland Health Care Systems (VAPHCS)
  • Temple University
  • University of Pittsburgh
  • Providence VA Medical Center
  • Medical University of South Carolina
  • WJB Dorn VAMC
  • Palmetto Research Center, LLC
  • VAMC Memphis
  • Meharry Medical College
  • Tennessee Valley Healthcare Systems-Nashville
  • Vanderbilt University
  • Austin Heart- Heart Hospital
  • Baylor Scott and White Heart and Vascular Hospital
  • Michael E. DeBakey VAMC, Houston
  • Houston Heart & Vascular Associates
  • Houston Methodist Research Institute-CCAT Pearland
  • St. David's Heath & Vascular PLLC
  • South Texas Veterans Healthcare System
  • STAR Clinical Trials
  • Austin Heart San Marcos
  • Baylor Scott and White Research Institute
  • University of Utah
  • George E. Wahlen Dept of VA Affairs Medical Center
  • VA Medical Center White River Junction
  • Inova Heart and Vascular Institute
  • Carient Heart & Vascular
  • Louis A Johnson VAMC
  • Gundersen Clinic
  • University of Wisconsin
  • Willam S. Middleton Memorial Veterans Hospital
  • University of Wisconsin Madison
  • Marshfield Clinic
  • Medical College of Wisconsin
  • Aurora Research Institute, LLC
  • Celement J. Zablocki VA Medical Center
  • TotalCardiology
  • University of Calgary
  • CK Hui Heart Centre, Royal Alexandra Hospital
  • Dr. MPJ Senaratne Professional Corporation
  • Northwest Echocardiolography
  • The CARe Clinic (Central Alberta Research)
  • University of Alberta Hospital- Mazankoski Heart Institute
  • Kelowna General Hospital
  • SMH Cardiology Clinical
  • Manna Research Inc. (Vancouver)
  • Vancouver General Hospital - Gordon Leslie Diamond Centre
  • St. Paul's Hospital
  • Victoria Heart Institute Foundation
  • St. Boniface Hospital/University of Manitoba
  • University of Sherbrooke
  • G.A Research Associates Ltd.
  • QEII Health Sciences
  • Brampton Research Assocaites
  • Manna Research Inc. (Burlington North)
  • Manna Research Inc. (Burlington South)
  • Cambridge Cardiac Care Center
  • Vizel Cardiac Research
  • Dr. Alan David Bell
  • Hamilton Health Sciences General Hospital/ McMaste
  • Queen's University CardioPulmonary Unit
  • St. Joseph's Health Care
  • Dixie Medical Group
  • Apple Hills Medical Associates
  • PACE
  • North York General Hospital
  • Sewa Ram Singal Med Prof Corporation
  • Heart Care Research
  • Dr. James Cha
  • Montfort Hospital and Ottawa Cardiovascular Centre
  • University of Ottawa Heart Institute
  • Heart Function Clinic Queensway Carleton
  • Kawartha Cardiology
  • Scarborough General Hospital
  • St. Catherines Hospital
  • Manna Research (Stoney Creek)
  • Health Sciences North Research Institute
  • Dr. D. Shukla Professional Medicine Corporation
  • Dr. R. Labonte Professional Medicine Corporation
  • Thunder Bay Regional Health Sciences Center
  • Sunnybrook Health Sciences Centre
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • Toronto General Hospital
  • Women's College Hospital
  • University of Toronto
  • iHealthCentre
  • CISSS de Laval, Hopital Cite de la Sante
  • Montreal Heart Institute
  • McGill University Health Centre
  • Jewish General Hospital
  • CIUSSS NÎM Hopital du Sacre-Coeur de Montreal
  • Manna Research Inc. (Montreal)
  • IUCPQ
  • Centre hospitalier régional de Lanaudière
  • CISSSI- Hopital Pierre-Le Gardeur
  • Centre Hospitalier de Regional Trois-Rivieres
  • Prairie Vascular Research Inc.
  • VA Caribbean Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Dose Influenza Vaccine

Standard Dose Influenza Vaccine

Arm Description

High Dose Influenza Vaccine

Standard Dose Influenza Vaccine

Outcomes

Primary Outcome Measures

All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season
Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season

Secondary Outcome Measures

Total Cardiopulmonary Hospitalizations or Death
Total (first and recurrent) cardiopulmonary hospitalizations or death
Cardiovascular Death or Hospitalization Within Each Vaccination Season
Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons
First cardiopulmonary Hospitalization or all-cause death across enrolling seasons
All-Cause Mortality
Number of patients with first occurrence of all-cause mortality

Full Information

First Posted
May 25, 2016
Last Updated
December 22, 2021
Sponsor
Brigham and Women's Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT02787044
Brief Title
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Acronym
INVESTED
Official Title
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Influenza leads to significant morbidity and mortality, particularly in patients with cardiovascular disease. Influenza-related death is more common in patients with cardiovascular disease than any other chronic health condition. Influenza infection has been temporally associated with acute cardiovascular events, such as acute coronary syndrome and acute heart failure. Due to the increased risk for influenza-related complications, annual influenza immunization is recommended by the Centers for Disease Control and Prevention, (CDC) the American Heart Association, and the American College of Cardiology, and widespread influenza vaccination has been associated with reduced cardiac-related hospital admissions, acute exacerbations of heart failure, and winter mortality. Moreover, a meta-analysis has shown that annual vaccination reduces the risk for major adverse cardiovascular events (MACE) by 36%, with a more prominent effect in those with recent acute myocardial infarction (AMI). Several lines of evidence suggest that a strategy of utilizing high-dose influenza vaccine in at risk cardiovascular patients would reduce morbidity and mortality. Immune responses to influenza vaccine, normally subject to variability by age and concomitant medical conditions, are substantially reduced in patients with heart failure evidenced by lower vaccine-induced antibody titers compared to healthy controls. In a randomized trial, antibody responses in patients with heart failure were augmented by using a higher dose of influenza vaccine. In a meta-analysis, higher dose influenza vaccination was associated with a 27% reduced risk for MACE compared to standard dose vaccine. A randomized study of high dose versus standard dose influenza vaccine in medically-stable patients over age 65 showed that participants receiving high dose vaccine had a 24% reduced risk of laboratory-confirmed influenza associated with protocol-defined influenza-like-illness, and had a low risk for adverse events. High dose influenza vaccine is FDA approved for use in medically stable adults over the age of 65, but has not been studied for patients under the age of 65 or in those with unstable, high risk medical conditions. The CDC does not preferentially recommend one influenza vaccine over another, and the optimal vaccine formulation that offers the most clinical protection in these high risk patients is unknown. The high morbidity and health care costs among patients with high risk cardiovascular disease along with the reduced immune responses to standard dose influenza vaccines in patients with heart failure provides a compelling rationale to investigate alternative influenza vaccination strategies in this group. INVESTED is an outcomes study in patients with recent acute myocardial infarction (AMI) or heart failure (HF) to test whether a four-fold higher dose of trivalent influenza vaccine will reduce morbidity and mortality compared to standard dose quadrivalent vaccine. INVESTED will test the hypothesize that high dose vaccine will reduce the composite of all cause death or cardiopulmonary hospitalizations in this population, with the following specific aims: Specific Aim 1. To test the hypothesis that high dose trivalent influenza vaccine will reduce the composite of death or cardiopulmonary events compared with standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients. Patients with recent AMI or HF hospitalization will be randomized to high dose versus standard dose vaccine for up to three influenza seasons. The primary endpoint will be time to first occurrence of death or cardiopulmonary hospitalization within each influenza season. Hospitalizations will be ascertained utilizing multiple approaches (phone, patient report, and electronic health records). Key secondary outcome measures will include total (first and recurrent) cardiopulmonary hospitalizations or death, time to first occurrence of cardiovascular death or cardiopulmonary hospitalization, time to occurrence of all-cause death or cardiopulmonary hospitalization across all enrolled influenza seasons, time to occurrence of all-cause death, and time to first occurrence of cardiopulmonary hospitalizations. Specific Aim 2. To test the hypothesis that antibody titers to influenza vaccine antigens are associated with cardiopulmonary outcomes. In a subset of participants, antibody titers by hemagglutination inhibition assays to influenza vaccine antigens at baseline and at 4 weeks following randomization will be determined, corresponding to achievement of maximal antibody titer levels after vaccination. The association between geometric mean titers post-vaccination and the occurrence of death or cardiopulmonary hospitalization (primary outcome measure of Specific Aim 1) will be assessed. Other key correlative study (immune) outcome measures will include: Change in antibody titers at 4 weeks post-vaccination from baseline to influenza vaccine antigens Seroconversion (demonstration of 4-fold rise in antibody concentrations from baseline) and seroprotection (demonstration of antibody titer level of 1:40) to A/H1N1, A/H3N2, and B-type vaccine antigens The results of this trial have the potential to inform health care policy regarding optimal influenza vaccination for individuals with high risk cardiovascular disease, which may in turn reduce morbidity from this annual threat to health stability in patients with cardiovascular conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction
Keywords
influenza vaccine, cardiopulmonary hospitalization, heart failure, myocardial infarction, clinical trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose Influenza Vaccine
Arm Type
Experimental
Arm Description
High Dose Influenza Vaccine
Arm Title
Standard Dose Influenza Vaccine
Arm Type
Active Comparator
Arm Description
Standard Dose Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
High Dose Trivalent Influenza Vaccine
Intervention Description
High Dose Trivalent Influenza Vaccine
Intervention Type
Biological
Intervention Name(s)
Standard Dose Quadrivalent Influenza Vaccine
Intervention Description
Standard Dose Quadrivalent Influenza Vaccine
Primary Outcome Measure Information:
Title
All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season
Description
Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season
Time Frame
Up to 1 year from vaccination (repeats seasonally)
Secondary Outcome Measure Information:
Title
Total Cardiopulmonary Hospitalizations or Death
Description
Total (first and recurrent) cardiopulmonary hospitalizations or death
Time Frame
Up to 3 years
Title
Cardiovascular Death or Hospitalization Within Each Vaccination Season
Description
Number of patients with first cardiovascular death or cardiovascular hospitalization within each influenza season
Time Frame
Up to one year from vaccination
Title
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons
Description
First cardiopulmonary Hospitalization or all-cause death across enrolling seasons
Time Frame
Up to three years
Title
All-Cause Mortality
Description
Number of patients with first occurrence of all-cause mortality
Time Frame
Up to 3 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared according to NIH data sharing rules
IPD Sharing Time Frame
Data will be available as per NIH guidelines on December 4, 2022 (2 years from the primary study publication date).
IPD Sharing Access Criteria
Data will be available to all qualified researchers based on the NIH BIOLINCC criteria.
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/
Citations:
PubMed Identifier
19398087
Citation
Vardeny O, Sweitzer NK, Detry MA, Moran JM, Johnson MR, Hayney MS. Decreased immune responses to influenza vaccination in patients with heart failure. J Card Fail. 2009 May;15(4):368-73. doi: 10.1016/j.cardfail.2008.11.009. Epub 2008 Dec 18.
Results Reference
background
PubMed Identifier
20030468
Citation
Vardeny O, Moran JJ, Sweitzer NK, Johnson MR, Hayney MS. Decreased T-cell responses to influenza vaccination in patients with heart failure. Pharmacotherapy. 2010 Jan;30(1):10-6. doi: 10.1592/phco.30.1.10.
Results Reference
background
PubMed Identifier
23291729
Citation
Van Ermen A, Hermanson MP, Moran JM, Sweitzer NK, Johnson MR, Vardeny O. Double dose vs. standard dose influenza vaccination in patients with heart failure: a pilot study. Eur J Heart Fail. 2013 May;15(5):560-4. doi: 10.1093/eurjhf/hfs207. Epub 2013 Jan 4.
Results Reference
background
PubMed Identifier
24361852
Citation
Albrecht CM, Sweitzer NK, Johnson MR, Vardeny O. Lack of persistence of influenza vaccine antibody titers in patients with heart failure. J Card Fail. 2014 Feb;20(2):105-9. doi: 10.1016/j.cardfail.2013.12.008. Epub 2013 Dec 19.
Results Reference
background
PubMed Identifier
25971953
Citation
Udell JA, Farkouh ME, Solomon SD, Vardeny O. Does influenza vaccination influence cardiovascular complications? Expert Rev Cardiovasc Ther. 2015 Jun;13(6):593-6. doi: 10.1586/14779072.2015.1044439. Epub 2015 May 14.
Results Reference
background
PubMed Identifier
26746371
Citation
Vardeny O, Claggett B, Udell JA, Packer M, Zile M, Rouleau J, Swedberg K, Desai AS, Lefkowitz M, Shi V, McMurray JJV, Solomon SD; PARADIGM-HF Investigators. Influenza Vaccination in Patients With Chronic Heart Failure: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Feb;4(2):152-158. doi: 10.1016/j.jchf.2015.10.012. Epub 2015 Dec 30.
Results Reference
background
PubMed Identifier
24150467
Citation
Udell JA, Zawi R, Bhatt DL, Keshtkar-Jahromi M, Gaughran F, Phrommintikul A, Ciszewski A, Vakili H, Hoffman EB, Farkouh ME, Cannon CP. Association between influenza vaccination and cardiovascular outcomes in high-risk patients: a meta-analysis. JAMA. 2013 Oct 23;310(16):1711-20. doi: 10.1001/jama.2013.279206.
Results Reference
background
PubMed Identifier
29909156
Citation
Vardeny O, Udell JA, Joseph J, Farkouh ME, Hernandez AF, McGeer AJ, Talbot HK, Bhatt DL, Cannon CP, Goodman SG, Anand I, DeMets DL, Temte J, Wittes J, Nichol K, Yancy CW, Gaziano JM, Cooper LS, Kim K, Solomon SD. High-dose influenza vaccine to reduce clinical outcomes in high-risk cardiovascular patients: Rationale and design of the INVESTED trial. Am Heart J. 2018 Aug;202:97-103. doi: 10.1016/j.ahj.2018.05.007. Epub 2018 May 23.
Results Reference
background
PubMed Identifier
33275134
Citation
Vardeny O, Kim K, Udell JA, Joseph J, Desai AS, Farkouh ME, Hegde SM, Hernandez AF, McGeer A, Talbot HK, Anand I, Bhatt DL, Cannon CP, DeMets D, Gaziano JM, Goodman SG, Nichol K, Tattersall MC, Temte JL, Wittes J, Yancy C, Claggett B, Chen Y, Mao L, Havighurst TC, Cooper LS, Solomon SD; INVESTED Committees and Investigators. 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. JAMA. 2021 Jan 5;325(1):39-49. doi: 10.1001/jama.2020.23649.
Results Reference
result
PubMed Identifier
30866676
Citation
Vardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N. Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance. Clin Trials. 2019 Jun;16(3):290-296. doi: 10.1177/1740774519832911. Epub 2019 Mar 13.
Results Reference
derived
Links:
URL
http://investedtrial.org
Description
INVESTED Trial Website

Learn more about this trial

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

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