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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design
American Heart Journal, Volume 212, Year 2019
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Description
Background: Influenza 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 Methods: In 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. Conclusion: This 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.gov NCT02762851 © 2019 The Authors
Authors & Co-Authors
Loeb, Mark B.
Canada, Hamilton
Mcmaster University
Dokainish, Hisham
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Dans, Antonio L.L.
Philippines, Manila
University of the Philippines Manila
Palileo-Villanueva, Lia M.
Philippines, Manila
University of the Philippines Manila
Roy, Ambuj A.
India, New Delhi
All India Institute of Medical Sciences, new Delhi
Karaye, Kamilu Musa
Nigeria, Kano
Bayero University
Zhu, Jun
Unknown Affiliation
Liang, Yan
Unknown Affiliation
Goma, Fastone M.
Zambia, Lusaka
University of Zambia
Damasceno, A. Antonio Moura
Mozambique, Maputo
Universidade Eduardo Mondlane
AlHabib, Khalid Faiz
Saudi Arabia, Riyadh
College of Medicine
Yonga, Gerald O.
Pakistan, Karachi
The Aga Khan University
Mondo, Charles Kiiza
Uganda, Kampala
Mulago Hospital
Al-Mahmeed, Wael Abdulrahman R.
United Arab Emirates, Abu Dhabi
Sheikh Khalifa Medical City
Al-Mulla, Arif Abudullatif
United Arab Emirates, Abu Dhabi
Sheikh Khalifa Medical City
Yusuf, Salim N.
Canada, Hamilton
Population Health Research Institute, Ontario
Canada, Hamilton
Mcmaster University
Statistics
Citations: 40
Authors: 16
Affiliations: 11
Identifiers
Doi:
10.1016/j.ahj.2019.02.009
ISSN:
00028703
Research Areas
Noncommunicable Diseases
Study Approach
Quantitative