Grant: Project Grant
Ottawa Hospital Research Institute
$302,176.00
A randomized trial of anti-arrhythmic agents to improve management of emergency department patients with acute atrial fibrillation
EF 2022-23
Résumé
Atrial fibrillation (AF) is a cardiac rhythm problem where the patient has a rapid and irregular heartbeat. We plan to study emergency department (ED) patients with acute-onset episodes of AF where the rapid heart rate requires urgent treatment to restore normal heart rhythm. Acute AF is the most common rhythm disorder managed in the ED. Most Canadian ED physicians treat these patients with electrical shock or drugs but the most used drug, IV procainamide, is slow and not very effective. A much newer drug, IV vernakalant, appears to be faster and more effective but is not commonly used in Canada. There never has been a head-to-head comparison of these two drugs.
We are conducting a clinical trial (RAFF4) to compare the two drugs and confirm that vernakalant is superior and therefore has the potential to allow AF patients to be discharged much more rapidly from our extremely crowded EDs, where cardiac monitors are at a premium. We have been conducting the RAFF4 trial with CIHR funding that will soon expire, and we have found our efforts to enroll at 12 Canadian hospitals across Canada have been hampered by the pandemic. With additional funding we can complete the target enrolment of 360 patients within 18 months. To date we have enrolled 180 patients, 75% in Ottawa.
The RAFF4 trial randomizes patients to receive either IV procainamide or vernakalant in an "open-label" design that allows the doctors and nurses to know which drug is being used and thus more closely follows real-life practice. Our primary outcome is conversion to normal heart rhythm. Other outcomes include length of stay in ED, adverse events, and 30-day follow-up status.
If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for drug cardioversion of acute AF. The study results should lead to higher rhythm conversion rates and more rapid discharges from our crowded EDs and impact care worldwide.
Programme
Project Grant
Bénéficiaire
Emplacement
Ontario, Canada
Type de bénéficiaire
Other
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
478770
Name
Stiell Ian G
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Health Services and Policy Research
Theme2
Clinical
Prcname2
Health Services Evaluation & Interventions Research
Projecttitle
A randomized trial of anti-arrhythmic agents to improve management of emergency department patients with acute atrial fibrillation
Programtype2
Operating Grants
Orgnameinp2
Ottawa Hospital Research Institute
Cihramount2
$302,176
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Atrial Fibrillation; Cardioversion; Clinical Trial; Drugs; Ed Crowding; Emergency Department; Patient Safety; Treatment
Abstract
Atrial fibrillation (AF) is a cardiac rhythm problem where the patient has a rapid and irregular heartbeat. We plan to study emergency department (ED) patients with acute-onset episodes of AF where the rapid heart rate requires urgent treatment to restore normal heart rhythm. Acute AF is the most common rhythm disorder managed in the ED. Most Canadian ED physicians treat these patients with electrical shock or drugs but the most used drug, IV procainamide, is slow and not very effective. A much newer drug, IV vernakalant, appears to be faster and more effective but is not commonly used in Canada. There never has been a head-to-head comparison of these two drugs.
We are conducting a clinical trial (RAFF4) to compare the two drugs and confirm that vernakalant is superior and therefore has the potential to allow AF patients to be discharged much more rapidly from our extremely crowded EDs, where cardiac monitors are at a premium. We have been conducting the RAFF4 trial with CIHR funding that will soon expire, and we have found our efforts to enroll at 12 Canadian hospitals across Canada have been hampered by the pandemic. With additional funding we can complete the target enrolment of 360 patients within 18 months. To date we have enrolled 180 patients, 75% in Ottawa.
The RAFF4 trial randomizes patients to receive either IV procainamide or vernakalant in an "open-label" design that allows the doctors and nurses to know which drug is being used and thus more closely follows real-life practice. Our primary outcome is conversion to normal heart rhythm. Other outcomes include length of stay in ED, adverse events, and 30-day follow-up status.
If vernakalant proves to be more effective, faster, and safer than IV procainamide, this will give clinicians an important alternative for drug cardioversion of acute AF. The study results should lead to higher rhythm conversion rates and more rapid discharges from our crowded EDs and impact care worldwide.
Competitiondate
202303
Approvedterm2
2 yrs 0 mth
Pinamesdelim
Stiell, Ian G
Approvedterm
2 ans 0 mois
Cihrcontribution2
~ $302,176~ $0~