A multi-centre, randomized, placebo controlled, trial. Participants at high-risk for vascular events from the network of INTER- CHF will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 600 participants will be enrolled prior to influenza season and randomized to either influenza vaccine or saline placebo.
Cardiovascular disease is a major cause of morbidity and mortality. There is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. There is some evidence that influenza vaccination may prevent such events but the data are inconclusive. The investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. Adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo. This pilot study will provide needed data to establish the feasibility of a larger study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
0.5 ml dose injected intramuscularly
0.5 ml dose injected intramuscularly
Maputo Central Hospital
Maputo, Mozambique
University of Philippines
Manila, Emita, Philippines
Mulago Hospital
Kampala, Uganda
Feasibility
If no more than 5% of all recruited subjects crossed over from one study group to the other, and if there is at least 98% follow up.
Time frame: Six months
Adverse cardiovascular event
The primary outcome will be a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria.
Time frame: Six months
Cardiovascular death
CV death alone will be a secondary outcome.
Time frame: Six months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.