Evidence map›Paper›PMID 29909156›Full record

ArticleAmerican heart journal2018

High-dose influenza vaccine to reduce clinical outcomes in high-risk cardiovascular patients: Rationale and design of the INVESTED trial.

Orly Vardeny, Jacob A Udell, Jacob Joseph, Michael E Farkouh, Adrian F Hernandez, Alison J McGeer, H Keipp Talbot, Deepak L Bhatt, Christopher P Cannon, Shaun G Goodman and 10 more

Registry-linked trialOpen access · greenAbstract readComparative StudyClinical Trial Protocol
In one paragraph

Article in American heart journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02787044 (INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02787044 phase4completednot on this map

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

TypeinterventionalSponsorBrigham and Women's HospitalRan2016 to 2020Enrolled5,388ConditionsHeart Failure, Myocardial InfarctionArmsHigh Dose Trivalent Influenza Vaccine, Standard Dose Quadrivalent Influenza Vaccine
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
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  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Absence of cardiac impairment in patients after severe acute respiratory syndrome coronavirus type 2 infection: A long-term follow-up study.Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance · 2024
    Article
  13. Review
  14. Vaccines and cardiovascular outcomes: lessons learned from influenza epidemics.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  15. The impact of influenza vaccination on cardiovascular diseases.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 2 countries.

Orly VardenyCenter for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, and University of Minnesota, Minneapolis, MN. Electronic address: ovardeny@umn.edu.
Jacob A UdellCardiovascular Division, Department of Medicine, Peter Munk Cardiac Centre, Toronto General Hospital and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.
Jacob JosephBoston VA Health Care System, and Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Michael E FarkouhCardiovascular Division, Department of Medicine, Peter Munk Cardiac Centre, University of Toronto, Toronto, Ontario, Canada.
Adrian F HernandezCardiology Division, Department of Medicine, Duke University School of Medicine, Durham, NC.
Alison J McGeerDepartment of Microbiology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.
H Keipp TalbotDivision of Infectious Diseases, Department of Medicine, Vanderbilt University, Nashville, TN.
Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center, and Harvard Medical School, Boston, MA.
Christopher P CannonBrigham and Women's Hospital Heart & Vascular Center, and Harvard Medical School, Boston, MA.
Shaun G GoodmanDivision of Cardiology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Inder AnandSan Diego and Minneapolis VA Health Care Systems and University of Minnesota, San Diego, CA, and Minneapolis, MN.
David L DeMetsDepartment of Statistics and Biostatistics, University of Wisconsin-Madison, Madison, WI.
Jon TemteDepartment of Family Medicine and Community Health, University of Wisconsin-Madison, Madison, WI.
Janet WittesStatistics Collaborative, Inc., Washington, DC.
Kristin NicholCenter for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, and University of Minnesota, Minneapolis, MN.
Clyde W YancyCardiovascular Division, Northwestern University Feinberg School of Medicine, Chicago, IL.
J Michael GazianoBoston VA Health Care System, and Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Lawton S CooperNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.
KyungMann KimDepartment of Statistics and Biostatistics, University of Wisconsin-Madison, Madison, WI.
Scott D SolomonBoston VA Health Care System, and Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Brigham and Women's Hospital · USMinneapolis VA Health Care System · USUniversity of Toronto · CAUniversity of Wisconsin–Madison · USDuke University · USHarvard University · USMount Sinai Hospital · CANational Heart Lung and Blood Institute · USNorthwestern University · USStatistics Collaborative · USUniversity of Minnesota · USUniversity of Wisconsin Health · USVA Boston Healthcare System · USVanderbilt University · USWomen's College Hospital · CA

Funding

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)U01HL130163 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SOLOMON, SCOTT DAVID, VARDENY, ORLY · 2016 to 2019
$19.1M
INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)-Data Coordinating CenterU01HL130204 · NHLBI · UNIVERSITY OF WISCONSIN-MADISON · PI KIM, KYUNGMANN · 2016 to 2020
$1.9M
NHLBI NIH HHS U01 HL130163NHLBI NIH HHS U01 HL130204
6 · The paper itself

Abstract

backgroundInfluenza leads to significant cardiopulmonary morbidity and mortality-particularly in patients with cardiovascular disease-that may be prevented with a standard influenza vaccine. However, patients with cardiovascular conditions have a reduced immune response to influenza vaccine, potentially resulting in reduced effectiveness for preventing clinical events. High-dose vaccine augments immune response in cardiac patients, suggesting that a high-dose influenza vaccination strategy may further reduce morbidity and mortality. Alternatively, broader coverage with an influenza vaccine containing an increased number of viral strains is an alternative strategy without direct evaluation. RESEARCH DESIGN AND

methodsINfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) is a pragmatic, randomized, double-blind, parallel-group, active-controlled trial comparing the effectiveness of an annual vaccination strategy of high-dose trivalent versus standard-dose quadrivalent influenza vaccine in patients with a history of recent heart failure or myocardial infarction hospitalization. The trial will enroll approximately 9,300 patients over 4 influenza seasons. The primary hypothesis is that high-dose influenza vaccine will reduce the composite outcome of all-cause mortality and hospitalization from a cardiovascular or pulmonary cause compared with standard-dose influenza vaccine within each enrolling season. Approximately 1,300 primary outcome events will provide >90% power to detect an 18% relative risk reduction at a 2-sided α level of .05.

conclusionINVESTED is the largest and longest study to assess whether high-dose influenza vaccine is superior to standard-dose influenza vaccine in reducing cardiopulmonary events in a high-risk cardiovascular population (ClinicalTrials.gov Identifier: NCT02787044).

Indexed as

AdultCardiovascular DiseasesDouble-Blind MethodFemaleHeart FailureHospitalizationHumansInfluenza, HumanInfluenza VaccinesMaleMulticenter Studies as TopicMyocardial InfarctionPneumoniaPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicResearch DesignInfluenza Vaccines

Identifiers

PMID29909156
PMCPMC6067954
OpenAlexW2803510421

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.