MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)
MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Marc McDowell, PharmD
- Phone Number: (708) 684-1078
- Email: marc.mcdowell@aah.org
Study Contact Backup
- Name: Thomas Szwajnos
- Email: Thomas.Szwajnos@aah.org
Study Locations
-
-
Illinois
-
Oak Lawn, Illinois, United States, 60453
- Advocate Christ Medical Center Emergency Department (ACMC ED)
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years or older
- Able to provide informed consent
- Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute
- Metoprolol as rate control agent
- English speaking
Exclusion Criteria:
- Hemodynamically unstable patients (SBP <90, MAP <65)
- Impaired consciousness
- Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and/or additional imaging
- Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis
- Rhythms other than atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response
- Acute myocardial infarction
- Contraindications to magnesium sulfate (including myasthenia gravis)
- Allergy or sensitivity to any study drugs
- Previously enrolled in this trial during a different patient encounter
- Withdrew from study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes.
Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes.
Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered.
Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
|
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Other Names:
|
|
Experimental: Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol
Study drug (Magnesium Sulfate 4 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes.
Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes.
Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered.
Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
|
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Other Names:
|
|
Placebo Comparator: Control Arm, normal saline followed by metoprolol
50ml 0.9% NaCl will be administered over a time interval of 15 minutes.
Intravenous metoprolol 5 mg will be immediately administered as an IV push over 2 minutes.
Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of saline will not be administered.
Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
|
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventricular rate control
Time Frame: Within the first 2 hours of intravenous magnesium administration
|
Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of < 120 beats per minute.
|
Within the first 2 hours of intravenous magnesium administration
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change in heart rate
Time Frame: up to 24 hours after magnesium infusion
|
Mean change in heart rate after the administration of magnesium sulfate
|
up to 24 hours after magnesium infusion
|
|
Incidence of hypotension
Time Frame: At 1 and 2 hours after magnesium administration
|
Systolic blood pressure < 90 or MAP < 65
|
At 1 and 2 hours after magnesium administration
|
|
Incidence of bradycardia
Time Frame: At 1 and 2 hours after magnesium administration
|
Heart rate < 60 beats per minute
|
At 1 and 2 hours after magnesium administration
|
|
Mean time to achieve goal heart rate
Time Frame: at 2 hours
|
Mean time to achieve goal heart rate at 2 hours
|
at 2 hours
|
|
Rate of conversion
Time Frame: 2 hours after administration of magnesium
|
Rate of conversion to normal sinus rhythm
|
2 hours after administration of magnesium
|
|
Clinical need for rescue medication administration
Time Frame: 2 hours from metoprolol administration
|
Dose of rescue medications given (magnesium and metoprolol)
|
2 hours from metoprolol administration
|
|
Mean change in heart rhythm
Time Frame: up to 24 hours after magnesium infusion
|
Mean change in heart rhythm after the administration of magnesium sulfate
|
up to 24 hours after magnesium infusion
|
|
Clinical need for rescue medication administration
Time Frame: 2 hours from metoprolol administration
|
Route of administration (IV or PO) for rescue medications (magnesium and metoprolol), if administered.
|
2 hours from metoprolol administration
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Marc McDowell, PharmD, Advocate Christ Medical Center Emergency Department
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Pathological Conditions, Signs and Symptoms
- Atrial Flutter
- Sulfur Compounds
- Inorganic Chemicals
- Chlorine Compounds
- Sulfur Acids
- Sodium Compounds
- Sulfates
- Sulfuric Acids
- Chlorides
- Hydrochloric Acid
- Magnesium Compounds
- Magnesium Sulfate
- Sodium Chloride
Other Study ID Numbers
Other Study ID Numbers
- IRB00146620
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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