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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | 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. |
|
| Placebo vaccine | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile saline | Other | 0.5 ml dose injected intramuscularly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular (CV) death | CV death alone will be a secondary outcome. | Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Loeb, MD, MSc. | Contact | 905-525-9140 | 26066 | loebm@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD, MSc. | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Douala General Hospital | Terminated | Douala | Cameroon | |||
| Fuwai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Causes of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf. | ||
| Background | Statistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011. | ||
| Background | Tracking Heart Disease and Stroke in Canada. Released June 2009 | ||
| 17336720 | Background | Remme WJ, Torp-Pedersen C, Cleland JG, Poole-Wilson PA, Metra M, Komajda M, Swedberg K, Di Lenarda A, Spark P, Scherhag A, Moullet C, Lukas MA. Carvedilol protects better against vascular events than metoprolol in heart failure: results from COMET. J Am Coll Cardiol. 2007 Mar 6;49(9):963-71. doi: 10.1016/j.jacc.2006.10.059. Epub 2007 Feb 20. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| inactivated trivalent influenza vaccine |
| Drug |
0.5 ml dose injected intramuscularly |
|
|
| Recruiting |
| Beijing |
| Xicheng District |
| 100037 |
| China |
|
| Centre for Chronic Disease Control | Recruiting | New Delhi | India |
|
| Aga Khan University | Recruiting | Nairobi | Kenya |
|
| American University of Beirut Medical Center | Not yet recruiting | Beirut | Lebanon |
|
| Maputo Central Hospital (Full Trial) | Recruiting | Maputo | Mozambique |
|
| Bayero University and Aminu Kano Teaching Hospital | Recruiting | Kano | Nigeria |
|
| University of Philippines | Recruiting | Manila | Emita | Philippines |
|
| King Saud Univeristy | Recruiting | Riyadh | Saudi Arabia |
|
| AlShaab Teaching Hospital | Terminated | Khartoum | Sudan |
| Mulago Hospital | Recruiting | Kampala | Uganda |
|
| Sheikh Khalifa Medical City | Recruiting | Abu Dhabi | United Arab Emirates |
|
| University of Zambia School of Medicine | Recruiting | Lusaka | Zambia |
|
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| D009976 |
| Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |