Evidence map›Paper›PMID 30933856›Full record

ArticleAmerican heart journal2019

Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design.

Mark Loeb, Hisham Dokainish, Antonio Dans, Lia M Palileo-Villanueva, Ambuj Roy, Kamilu Karaye, Jun Zhu, Yan Liang, Fastone Goma, Albertino Damasceno and 7 more

Erratum issuedOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in American heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
5.4field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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  13. Vaccines and cardiovascular outcomes: lessons learned from influenza epidemics.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  14. The impact of influenza vaccination on cardiovascular diseases.European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  15. What if flu vaccination is the most responsible thing to do for cardiovascular health in the upcoming season?European heart journal supplements : journal of the European Society of Cardiology · 2023
    Article
  16. Risk of arterial and venous thromboses after COVID-19.The Lancet. Infectious diseases · 2022
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 11 countries.

Mark LoebDepartment of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada; Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Institute for Infectious Disease Research, McMaster University, Hamilton, Ontario, Canada. Electronic address: loebm@mcmaster.ca.
Hisham DokainishPopulation Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Antonio DansUniversity of the Philippines Manila, Manila, Philippines.
Lia M Palileo-VillanuevaUniversity of the Philippines Manila, Manila, Philippines.
Ambuj RoyAll India Institute of Medical Sciences, Delhi, India.
Kamilu KarayeBayero University and Aminu Kano Teaching Hospital, Kano, Nigeria.
Jun ZhuFuWai Hospital, Beijing, China.
Yan LiangFuWai Hospital, Beijing, China.
Fastone GomaUniversity of Zambia, Zambia.
Albertino DamascenoDepartment of Medicine, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
Khalid F AlHabibDepartment of Cardiac Sciences, King Fahad Cardiac Center, College of Medicine, King Saud University, Saudi Arabia.
Gerald YongaAga Khan University, Kenya.
Charles MondoMulago Hospital, Uganda.
Wael AlmahmeedSheikh Khalifa Medical City, United Arab Emirates.
Arif Al MullaSheikh Khalifa Medical City, United Arab Emirates.
Salim YusufPopulation Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
IVVE investigators
Fu Wai Hospital · CNPopulation Health Research Institute · CAShaikh Khalifa Medical City · AEUniversity of the Philippines Manila · PHAga Khan University Nairobi · KEAll India Institute of Medical Sciences · INBayero University Kano · NGEduardo Mondlane University · MZKing Saud University · SAMcMaster University · CAMulago Hospital · UGUniversity of Zambia · ZM

Funding

Medical Research Council MR/N005759/1Wellcome Trust
6 · The paper itself

Abstract

backgroundInfluenza is associated with an increase in the risk of cardiac and other vascular events. Observational data and small randomized trials suggest that influenza vaccination may reduce such adverse vascular events. RESEARCH DESIGN AND

methodsIn a randomized controlled trial patients with heart failure are randomized to receive either inactivated influenza vaccine or placebo annually for 3 years. Patients aged ≥18 years with a clinical diagnosis of heart failure and NYHA functional class II, III and IV are eligible. Five thousand patients from 10 countries where influenza vaccination is not common (Asia, the Middle East, and Africa) have been enrolled. The primary outcome is a composite of the following: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Analyses will be based on comparing event rates between influenza vaccine and control groups and will include time to event, rate comparisons using Poisson methods, and logistic regression. The analysis will be conducted by intention to treat i.e. patients will be analyzed in the group in which they were assigned. Multivariable secondary analyses to assess whether variables such as age, sex, seasonality modify the benefits of vaccination are also planned for the primary outcome.

conclusionThis is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals. TRIAL REGISTRATION NUMBER: Clinicaltrials.govNCT02762851.

Indexed as

AdolescentAdultAgedCause of DeathFemaleFollow-Up StudiesGlobal HealthHeart FailureHumansIncidenceInfluenza, HumanInfluenza VaccinesMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicInfluenza Vaccines

Identifiers

PMID30933856
PMCPMC6543876
OpenAlexW2921331215

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.