Clinical trial NCT02787044: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Official title: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Myocardial Infarction
Keywords: influenza vaccine
cardiopulmonary hospitalization
heart failure
myocardial infarction
clinical trial
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Wisconsin, Madison
name: University of Toronto
name: Boston VA Research Institute, Inc.
name: Patient-Centered Outcomes Research Institute
name: University of Minnesota
First posted: 2016-06-01
Enrollment: 5388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season
timeFrame: Up to 1 year from vaccination (repeats seasonally)
Secondary outcomes:
measure: Total Cardiopulmonary Hospitalizations or Death
timeFrame: Up to 3 years
measure: Cardiovascular Death or Hospitalization Within Each Vaccination Season
timeFrame: Up to one year from vaccination
measure: Death or Cardiopulmonary Hospitalization Across Enrolling Seasons
timeFrame: Up to three years
measure: All-Cause Mortality
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VAMC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Hypertension Program
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart & Vascular Institute
state: Alaska
city: Tucson
country: United States
facility: Banner University Medicine North
state: Arizona
city: Tucson
country: United States
facility: University of Arizona- Sarver Heart Center
state: Arizona
city: Little Rock
country: United States
facility: CAVHS
state: Arkansas
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: Long Beach VAMC
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: West Haven
country: United States
facility: VA West Haven
state: Connecticut
city: Washington
country: United States
facility: Washington DC VAMC
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Gainesville
country: United States
facility: N FL/S GA Veterans Health System
state: Florida
city: Gainesville
country: United States
facility: OneFlorida CDRN
state: Florida
city: Largo
country: United States
facility: Clearwater Cardiovascular Consultants-Largo
state: Florida
city: Miami
country: United States
facility: Inpatient Research Corporation
state: Florida
city: Miami
country: United States
facility: ITB Research
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group Research Center
state: Florida
city: Safety Harbor
country: United States
facility: Clearwater Cardiovascular Consultants-SH
state: Florida
city: Tallahassee
country: United States
facility: Bond Community Health Center, Inc.
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Health Care System
state: Georgia
city: Fayetteville
country: United States
facility: Peidmont Fayette
state: Georgia
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research
state: Illinois
city: Lake Forest
country: United States
facility: Northwester Medicine Lake Forest
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: North Chicago
country: United States
facility: Captain James A. Lovell Federal Health Care Center
state: Illinois
city: Peoria
country: United States
facility: UnityPoint Health Methodist
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Leavenworth
country: United States
facility: VA Eastern Kansas Health Care System
state: Kansas
city: Louisville
country: United States
facility: Robley Rex VA
state: Kentucky
city: Hammond
country: United States
facility: The Heart Clinic of Hamond
state: Louisiana
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Healthcare System
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System- Baton Rouge
state: Louisiana
city: Bedford
country: United States
facility: ENRM VA Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Faulkner Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Haverhill
country: United States
facility: Pentucket Medical Associates
state: Massachusetts
city: Natick
country: United States
facility: Charles River Medical Associates
state: Massachusetts
city: West Roxbury
country: United States
facility: Boston/West Roxbury VA Hospital
state: Massachusetts
city: West Roxbury
country: United States
facility: VA Boston Healthcase System
state: Massachusetts
city: Ann Arbor
country: United States
facility: VA Ann Harbor Healthcare System
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: HealthPartners - Riverside Research
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast Medical Research Institute
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Grand Island
country: United States
facility: Nebraska Heart Institute- Grand Island
state: Nebraska
city: Lebanon
country: United States
facility: Darthmouth-Hitchcock Medical Center
state: New Hampshire
city: Elmer
country: United States
facility: Cardio Assoc. of the Del. Valley- Elmer
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardio. Assoc. of the Del. Valley- Haddon Heights
state: New Jersey
city: Sewell
country: United States
facility: Cardio. Assoc. of the Del. Valley- Sewell
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Flushing
country: United States
facility: New York Presbyterian Queens Bayside/Whitestone
state: New York
city: Flushing
country: United States
facility: New York Presbyterian/Queens
state: New York
city: Flushing
country: United States
facility: NYPQ - Cardiology Outpatient Clinic
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: New York VA
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Asheville
country: United States
facility: Charles George VA
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke
state: North Carolina
city: Cleveland
country: United States
facility: Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Springfield
country: United States
facility: Heart House Research Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science
state: Oregon
city: Portland
country: United States
facility: VA Portland Health Care Systems (VAPHCS)
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: WJB Dorn VAMC
state: South Carolina
city: Spartanburg
country: United States
facility: Palmetto Research Center, LLC
state: South Carolina
city: Memphis
country: United States
facility: VAMC Memphis
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Valley Healthcare Systems-Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Austin Heart- Heart Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor Scott and White Heart and Vascular Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VAMC, Houston
state: Texas
city: Kingwood
country: United States
facility: Houston Heart & Vascular Associates
state: Texas
city: Pearland
country: United States
facility: Houston Methodist Research Institute-CCAT Pearland
state: Texas
city: Round Rock
country: United States
facility: St. David's Heath & Vascular PLLC
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Healthcare System
state: Texas
city: San Antonio
country: United States
facility: STAR Clinical Trials
state: Texas
city: San Marcos
country: United States
facility: Austin Heart San Marcos
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: George E. Wahlen Dept of VA Affairs Medical Center
state: Utah
city: White River Junction
country: United States
facility: VA Medical Center White River Junction
state: Vermont
city: Alexandria
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Manassas
country: United States
facility: Carient Heart & Vascular
state: Virginia
city: Clarksburg
country: United States
facility: Louis A Johnson VAMC
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Madison
country: United States
facility: Willam S. Middleton Memorial Veterans Hospital
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Madison
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Research Institute, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Celement J. Zablocki VA Medical Center
state: Wisconsin
city: Calgary
country: Canada
facility: TotalCardiology
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: CK Hui Heart Centre, Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Dr. MPJ Senaratne Professional Corporation
state: Alberta
city: Grande Prairie
country: Canada
facility: Northwest Echocardiolography
state: Alberta
city: Red Deer
country: Canada
facility: The CARe Clinic (Central Alberta Research)
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital- Mazankoski Heart Institute
state: British Columbia
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: Surrey
country: Canada
facility: SMH Cardiology Clinical
state: British Columbia
city: Vancouver
country: Canada
facility: Manna Research Inc. (Vancouver)
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Gordon Leslie Diamond Centre
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital/University of Manitoba
state: Manitoba
city: Dieppe
country: Canada
facility: University of Sherbrooke
state: New Brunswick
city: Moncton
country: Canada
facility: G.A Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences
state: Nova Scotia
city: Brampton
country: Canada
facility: Brampton Research Assocaites
state: Ontario
city: Burlington
country: Canada
facility: Manna Research Inc. (Burlington North)
state: Ontario
city: Burlington
country: Canada
facility: Manna Research Inc. (Burlington South)
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Center
state: Ontario
city: Cambridge
country: Canada
facility: Vizel Cardiac Research
state: Ontario
city: Downsview
country: Canada
facility: Dr. Alan David Bell
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences General Hospital/ McMaste
state: Ontario
city: Kingston
country: Canada
facility: Queen's University CardioPulmonary Unit
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Mississauga
country: Canada
facility: Dixie Medical Group
state: Ontario
city: Mississauga
country: Canada
facility: Apple Hills Medical Associates
state: Ontario
city: Newmarket
country: Canada
facility: PACE
state: Ontario
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: North York
country: Canada
facility: Sewa Ram Singal Med Prof Corporation
state: Ontario
city: Oshawa
country: Canada
facility: Heart Care Research
state: Ontario
city: Oshawa
country: Canada
facility: Dr. James Cha
state: Ontario
city: Ottawa
country: Canada
facility: Montfort Hospital and Ottawa Cardiovascular Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Ottawa
country: Canada
facility: Heart Function Clinic Queensway Carleton
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough General Hospital
state: Ontario
city: St. Catherines
country: Canada
facility: St. Catherines Hospital
state: Ontario
city: Stoney Creek
country: Canada
facility: Manna Research (Stoney Creek)
state: Ontario
city: Sudbury
country: Canada
facility: Health Sciences North Research Institute
state: Ontario
city: Sudbury
country: Canada
facility: Dr. D. Shukla Professional Medicine Corporation
state: Ontario
city: Sudbury
country: Canada
facility: Dr. R. Labonte Professional Medicine Corporation
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Vaughan
country: Canada
facility: iHealthCentre
state: Ontario
city: Laval
country: Canada
facility: CISSS de Laval, Hopital Cite de la Sante
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS NÎM Hopital du Sacre-Coeur de Montreal
state: Quebec
city: Montréal
country: Canada
facility: Manna Research Inc. (Montreal)
state: Quebec
city: Quebec City
country: Canada
facility: IUCPQ
state: Quebec
city: St-Charles Borromee
country: Canada
facility: Centre hospitalier régional de Lanaudière
state: Quebec
city: Terrebonne
country: Canada
facility: CISSSI- Hopital Pierre-Le Gardeur
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre Hospitalier de Regional Trois-Rivieres
state: Quebec
city: Regina
country: Canada
facility: Prairie Vascular Research Inc.
state: Saskatchewan
city: San Juan
country: Puerto Rico
facility: VA Caribbean Healthcare System
Study officials:
affiliation: University of Minnesota
name: Orly Vardeny, PharmD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Scott D Solomon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: KyungMann Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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