A Phase 4 interventional study of Sterile saline and inactivated trivalent influenza vaccine in Heart Failure and Influenza, sponsored by McMaster University. Status unknown at 13 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-26.
Sponsored by McMaster University · Phase 4, Interventional, and Treatment
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. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.
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 each year for three consecutive years. They will be followed over six months for a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events in patients with heart failure would lead to a major change in how these patients are managed. Given the large burden of disease both in Canada and globally, the possibility to reduce cardiovascular and stroke related death is a compelling reason to conduct this trial.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants at high risk for adverse vascular events will be immunized with 0.5 ml dose of inactivated trivalent influenza vaccine prior to the influenza season.
Drug: inactivated trivalent influenza vaccine
Participants at high risk for adverse vascular events will be vaccinated with a 0.5 ml dose of sterile saline prior to the influenza season.
Other: Sterile saline
0.5 ml dose injected intramuscularly
0.5 ml dose injected intramuscularly
Also known as: VAXIGRIP vaccine
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 (CV) death
CV death alone will be a secondary outcome.
Time frame: Six months
Plan to share: No
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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