Heart FailurePhase 4RCT-IVVENCT02762851
Influenza Vaccine To Prevent Adverse Vascular Events (RCT-IVVE)
A Phase 4 study testing Sterile saline and inactivated trivalent influenza vaccine in people with Heart Failure and Influenza, run by McMaster University at 13 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Influenza
- What is being tested?
- Sterile saline and inactivated trivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 13 sitesin 13 countries
- Study dates
- Jun 2016to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV
Who cannot join
- 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
Trial locations and contacts
13 sites in 13 countries.
13 sites in 13 countries
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Xicheng District, 100037
Yan Liang, MD, yan.liang@phri.ca
Jun Zhu, MD, junzhuld@hotmail.com
India1 site, 1 recruiting
- Recruiting
Centre for Chronic Disease Control
New Delhi
Dorairaj Prabhakaran, MD, dprabhakaran@ccdcindia.org
Ambuj Roy, MD
Kenya1 site, 1 recruiting
- Recruiting
Aga Khan University
Nairobi
Gerald Yonga, MD, gerald.yonga@aku.edu
Lebanon1 site, 1 recruiting
- Not yet recruiting
American University of Beirut Medical Center
Beirut
Marwan Refaat, MD, +961-1-350000 ext. 5825, mr48@aub.edu.lb
Mozambique1 site, 1 recruiting
- Recruiting
Maputo Central Hospital (Full Trial)
Maputo
Albertino Damasceno, MD, 258 2131 0828, tino_7117@yahoo.com.br
Nigeria1 site, 1 recruiting
- Recruiting
Bayero University and Aminu Kano Teaching Hospital
Kano
Kamilu Karaye, MD, 234 803 704 2171, kkaraye@yahoo.co.uk
Philippines1 site, 1 recruiting
- Recruiting
University of Philippines
Manila, Emita
Lia Palileo, MD, liapalileo@gmail.com
Antonio Dans, MD
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud Univeristy
Riyadh
Khalid Al-Habib, MD, 966 1 288 9999, khalidalhabib13@hotmail.com
Uganda1 site, 1 recruiting
- Recruiting
Mulago Hospital
Kampala
Charles Mondo, MD, 256 772 462370, charles_mondo@yahoo.com.au
United Arab Emirates1 site, 1 recruiting
- Recruiting
Sheikh Khalifa Medical City
Abu Dhabi
Wael Almahmeed, MD, wmahmeed@emirates.net.ae
Zambia1 site, 1 recruiting
- Recruiting
University of Zambia School of Medicine
Lusaka
Fastone Goma, MD, gomafm@yahoo.co.uk
About this study
Official title: A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events
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.
Read the detailed description
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
- Heart Failure, Influenza
- Being tested
- Sterile saline, inactivated trivalent influenza vaccine
- Keywords
- Influenza, Vaccine, Heart failure, Vascular
- Medical subject headings
- Heart Failure, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile salineOther
0.5 ml dose injected intramuscularly
inactivated trivalent influenza vaccineDrug
Also called VAXIGRIP vaccine
0.5 ml dose injected intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: inactivated trivalent influenza vaccine |
| 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. Receives: Other: Sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (1)
Cardiovascular (CV) death
CV death alone will be a secondary outcome.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, MD, MSc., Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762851
- Sponsor's protocol ID
- RCT-IVVE 2015
- Acronym
- RCT-IVVE
- Status last verified
- Oct 2018
- First submitted
- 3 May 2016
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Causes of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf.
Statistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011.
Tracking Heart Disease and Stroke in Canada. Released June 2009
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.
PubMed 17336720Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954.
PubMed 23478743Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
PubMed 19001508Bohm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet. 2010 Sep 11;376(9744):886-94. doi: 10.1016/S0140-6736(10)61259-7.
PubMed 20801495Homma S, Thompson JL, Pullicino PM, Levin B, Freudenberger RS, Teerlink JR, Ammon SE, Graham S, Sacco RL, Mann DL, Mohr JP, Massie BM, Labovitz AJ, Anker SD, Lok DJ, Ponikowski P, Estol CJ, Lip GY, Di Tullio MR, Sanford AR, Mejia V, Gabriel AP, del Valle ML, Buchsbaum R; WARCEF Investigators. Warfarin and aspirin in patients with heart failure and sinus rhythm. N Engl J Med. 2012 May 17;366(20):1859-69. doi: 10.1056/NEJMoa1202299. Epub 2012 May 2.
PubMed 22551105Kinlay S, Ganz P. Role of endothelial dysfunction in coronary artery disease and implications for therapy. Am J Cardiol. 1997 Nov 6;80(9A):11I-16I. doi: 10.1016/s0002-9149(97)00793-5.
PubMed 9375937Chan NN, Colhoun HM, Vallance P. Cardiovascular risk factors as determinants of endothelium-dependent and endothelium-independent vascular reactivity in the general population. J Am Coll Cardiol. 2001 Dec;38(7):1814-20. doi: 10.1016/s0735-1097(01)01669-2.
PubMed 11738279Davies MJ. The composition of coronary-artery plaques. N Engl J Med. 1997 May 1;336(18):1312-4. doi: 10.1056/NEJM199705013361809. No abstract available.
PubMed 9113937Wanishsawad C, Zhou YF, Epstein SE. Chlamydia pneumoniae-induced transactivation of the major immediate early promoter of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Infect Dis. 2000 Feb;181(2):787-90. doi: 10.1086/315235.
PubMed 10669378Conti CR. Vascular events responsible for thrombotic occlusion of a blood vessel. Clin Cardiol. 1993 Nov;16(11):761-2. doi: 10.1002/clc.4960161103.
PubMed 8269651Lundman P, Eriksson M, Schenck-Gustafsson K, Karpe F, Tornvall P. Transient triglyceridemia decreases vascular reactivity in young, healthy men without risk factors for coronary heart disease. Circulation. 1997 Nov 18;96(10):3266-8. doi: 10.1161/01.cir.96.10.3266.
PubMed 9396413Kawano H, Motoyama T, Hirashima O, Hirai N, Miyao Y, Sakamoto T, Kugiyama K, Ogawa H, Yasue H. Hyperglycemia rapidly suppresses flow-mediated endothelium-dependent vasodilation of brachial artery. J Am Coll Cardiol. 1999 Jul;34(1):146-54. doi: 10.1016/s0735-1097(99)00168-0.
PubMed 10400004
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Influenza Vaccine to Prevent Adverse Vascular Events
- ClinicalTrials.gov ID
- NCT02762851
- Acronym / sponsor ID
- RCT-IVVE / RCT-IVVE 2015
- Conditions
- Heart Failure, Influenza
- Keywords
- Influenza, Vaccine, Heart failure, Vascular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine | Experimental | Drug: inactivated trivalent influenza vaccineParticipants 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 | Other: Sterile salineParticipants at high risk for adverse vascular events will be vaccinated with a 0.5 ml dose of sterile saline prior to the influenza season. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years and NYHA (New York Heart Association) functional class II, III and IV
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile saline0.5 ml dose injected intramuscularly | Other | Placebo vaccine |
| inactivated trivalent influenza vaccineAlso: VAXIGRIP vaccine0.5 ml dose injected intramuscularly | Drug | Influenza vaccine |
Primary outcome
Adverse cardiovascular event
Time frame: Six months
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.
1 secondary outcome
Cardiovascular (CV) death
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- BackgroundCauses of death 2008, World Health Organization, Geneva, http://www.who.int/healthinfo/ global_burden_disease/ cod_2008_sources_methods.pdf.
- BackgroundStatistics Canada. Morality, Summary List of Causes 2008. Released October 18, 2011.
- BackgroundTracking Heart Disease and Stroke in Canada. Released June 2009
- Background: PubMed 17336720Remme 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.
- Background: PubMed 23478743Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP; ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA. 2013 Mar 20;309(11):1125-35. doi: 10.1001/jama.2013.1954.
- Background: PubMed 19001508Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
- Background: PubMed 20801495Bohm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet. 2010 Sep 11;376(9744):886-94. doi: 10.1016/S0140-6736(10)61259-7.
- Background: PubMed 22551105Homma S, Thompson JL, Pullicino PM, Levin B, Freudenberger RS, Teerlink JR, Ammon SE, Graham S, Sacco RL, Mann DL, Mohr JP, Massie BM, Labovitz AJ, Anker SD, Lok DJ, Ponikowski P, Estol CJ, Lip GY, Di Tullio MR, Sanford AR, Mejia V, Gabriel AP, del Valle ML, Buchsbaum R; WARCEF Investigators. Warfarin and aspirin in patients with heart failure and sinus rhythm. N Engl J Med. 2012 May 17;366(20):1859-69. doi: 10.1056/NEJMoa1202299. Epub 2012 May 2.
- Background: PubMed 9375937Kinlay S, Ganz P. Role of endothelial dysfunction in coronary artery disease and implications for therapy. Am J Cardiol. 1997 Nov 6;80(9A):11I-16I. doi: 10.1016/s0002-9149(97)00793-5.
- Background: PubMed 11738279Chan NN, Colhoun HM, Vallance P. Cardiovascular risk factors as determinants of endothelium-dependent and endothelium-independent vascular reactivity in the general population. J Am Coll Cardiol. 2001 Dec;38(7):1814-20. doi: 10.1016/s0735-1097(01)01669-2.
- Background: PubMed 9113937Davies MJ. The composition of coronary-artery plaques. N Engl J Med. 1997 May 1;336(18):1312-4. doi: 10.1056/NEJM199705013361809. No abstract available.
- Background: PubMed 10669378Wanishsawad C, Zhou YF, Epstein SE. Chlamydia pneumoniae-induced transactivation of the major immediate early promoter of cytomegalovirus: potential synergy of infectious agents in the pathogenesis of atherosclerosis. J Infect Dis. 2000 Feb;181(2):787-90. doi: 10.1086/315235.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Loeb, MD, MSc. principal investigator
McMaster University
13 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sterile saline and inactivated trivalent influenza vaccine in people with Heart Failure and Influenza, run by McMaster University at 13 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Cameroon, China, India, Kenya, Lebanon and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Loeb, MD, MSc. (905-525-9140 ext. 26066, loebm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse cardiovascular event (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02762851, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.