Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)
NCT ID: NCT02762851
Last Updated: 2018-10-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
5000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-06-30
Study Completion Date
2020-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Heart Failure
Influenza
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Influenza vaccine
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.
Group Type
EXPERIMENTAL
inactivated trivalent influenza vaccine
Intervention Type
DRUG
0.5 ml dose injected intramuscularly
Placebo 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.
Group Type
PLACEBO_COMPARATOR
Sterile saline
Intervention Type
OTHER
0.5 ml dose injected intramuscularly
Interventions
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Sterile saline
0.5 ml dose injected intramuscularly
Intervention Type
OTHER
inactivated trivalent influenza vaccine
0.5 ml dose injected intramuscularly
Intervention Type
DRUG
Other Intervention Names
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VAXIGRIP vaccine
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV
Exclusion Criteria
* Anaphylactic reaction to a previous dose of TIV(trivalent influenza vaccine)
* Known IgE( Immunoglobulin E)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
* Anaphylactic reaction to neomycin
* Patients who have had influenza vaccine in two of the three previous years
* Known IgE( Immunoglobulin E)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
* Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
* Anaphylactic reaction to neomycin
* Patients who have had influenza vaccine in two of the three previous years
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mark Loeb, MD, MSc.
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Douala General Hospital
Douala, , Cameroon
Site Status
TERMINATED
Fuwai Hospital
Beijing, Xicheng District, China
Site Status
RECRUITING
Centre for Chronic Disease Control
New Delhi, , India
Site Status
RECRUITING
Aga Khan University
Nairobi, , Kenya
Site Status
RECRUITING
American University of Beirut Medical Center
Beirut, , Lebanon
Site Status
NOT_YET_RECRUITING
Maputo Central Hospital (Full Trial)
Maputo, , Mozambique
Site Status
RECRUITING
Bayero University and Aminu Kano Teaching Hospital
Kano, , Nigeria
Site Status
RECRUITING
University of Philippines
Manila, Emita, Philippines
Site Status
RECRUITING
King Saud Univeristy
Riyadh, , Saudi Arabia
Site Status
RECRUITING
AlShaab Teaching Hospital
Khartoum, , Sudan
Site Status
TERMINATED
Mulago Hospital
Kampala, , Uganda
Site Status
RECRUITING
Sheikh Khalifa Medical City
Abu Dhabi, , United Arab Emirates
Site Status
RECRUITING
University of Zambia School of Medicine
Lusaka, , Zambia
Site Status
RECRUITING
Countries
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Cameroon
China
India
Kenya
Lebanon
Mozambique
Nigeria
Philippines
Saudi Arabia
Sudan
Uganda
United Arab Emirates
Zambia
Central Contacts
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Facility Contacts
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References
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Population Health Research Institute http://www.phri.ca/
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ORIGIN Trial Investigators; Gerstein HC, Bosch J, Dagenais GR, Diaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.
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ORIGIN Trial Investigators; Bosch J, Gerstein HC, Dagenais GR, Diaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. doi: 10.1056/NEJMoa1203859. Epub 2012 Jun 11.
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ACCORD Study Group; Gerstein HC, Miller ME, Genuth S, Ismail-Beigi F, Buse JB, Goff DC Jr, Probstfield JL, Cushman WC, Ginsberg HN, Bigger JT, Grimm RH Jr, Byington RP, Rosenberg YD, Friedewald WT. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med. 2011 Mar 3;364(9):818-28. doi: 10.1056/NEJMoa1006524.
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CURRENT-OASIS 7 Investigators; Mehta SR, Bassand JP, Chrolavicius S, Diaz R, Eikelboom JW, Fox KA, Granger CB, Jolly S, Joyner CD, Rupprecht HJ, Widimsky P, Afzal R, Pogue J, Yusuf S. Dose comparisons of clopidogrel and aspirin in acute coronary syndromes. N Engl J Med. 2010 Sep 2;363(10):930-42. doi: 10.1056/NEJMoa0909475.
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ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, Crouse JR 3rd, Leiter LA, Linz P, Friedewald WT, Buse JB, Gerstein HC, Probstfield J, Grimm RH, Ismail-Beigi F, Bigger JT, Goff DC Jr, Cushman WC, Simons-Morton DG, Byington RP. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1563-74. doi: 10.1056/NEJMoa1001282. Epub 2010 Mar 14.
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ACCORD Study Group; Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010 Apr 29;362(17):1575-85. doi: 10.1056/NEJMoa1001286. Epub 2010 Mar 14.
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Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
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DataFax - Data Management Software for Clinical Trials. http://www.datafax.com/; accessed February 15, 2013.
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Loeb M, Roy A, Dokainish H, Dans A, Palileo-Villanueva LM, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, Alhabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Thanabalan V, Rao-Melacini P, Grinvalds A, McCready T, Bangdiwala SI, Yusuf S; Influenza Vaccine to Prevent Adverse Vascular Events investigators. Influenza vaccine to reduce adverse vascular events in patients with heart failure: a multinational randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2022 Dec;10(12):e1835-e1844. doi: 10.1016/S2214-109X(22)00432-6.
Reference Type
DERIVED
Loeb M, Dokainish H, Dans A, Palileo-Villanueva LM, Roy A, Karaye K, Zhu J, Liang Y, Goma F, Damasceno A, AlHabib KF, Yonga G, Mondo C, Almahmeed W, Al Mulla A, Yusuf S; IVVE investigators. Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design. Am Heart J. 2019 Jun;212:36-44. doi: 10.1016/j.ahj.2019.02.009. Epub 2019 Mar 11.
Reference Type
DERIVED
Other Identifiers
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RCT-IVVE 2015
Identifier Type: -
Identifier Source: org_study_id
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