Antiarrhythmic Agent
Magnesium sulfate and then Digoxin for Atrial Fibrillation
Phase 3
Recruiting
Led By Brian H Cuthbertson, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treating physician determines the patient has clinically significant AF that requires medical treatment
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up90 days
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Study Summary
This trial will compare magnesium sulfate to magnesium sulfate + digoxin to see which is more effective in treating atrial fibrillation.
Eligible Conditions
- Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your doctor has determined that you have a serious heart condition called atrial fibrillation (AF) that needs to be treated with medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate control (<110 beats per minute) and/or restoration of normal sinus
ICU free days
Secondary outcome measures
Avoidance of amiodarone
Continuation of trial intervention
Heart rate
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental armExperimental Treatment1 Intervention
Intravenous magnesium sulphate as first line followed by digoxin IV loading as second line and then amiodarone IV as third line treatments for fast AF
Group II: Standard of care armActive Control1 Intervention
Intravenous amiodarone as compactor group intervention
Find a site
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
633 Previous Clinical Trials
1,478,137 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
5,735 Patients Enrolled for Atrial Fibrillation
Sunnybrook Research InstituteOTHER
29 Previous Clinical Trials
10,422 Total Patients Enrolled
Brian H Cuthbertson, MDPrincipal Investigator
Sunnybrook Health Sciences CentreMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please tell me how many people are taking part in this experimental procedure?
"That is accurate. The listing on clinicaltrials.gov says that this trial, which was first posted on January 5th 2022, is currently looking for 200 patients at 1 site."
Answered by AI
Has the FDA greenlit the use of Magnesium sulfate in tandem with Digoxin?
"There is some evidence from past trials to support the efficacy of magnesium sulfate and digoxin, so these drugs were given a safety score of 3."
Answered by AI
Recent research and studies