Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified September 2025 by Wake Forest University Health Sciences
Sponsor
Wake Forest University Health Sciences
Information Provided by (Responsible Party)
Wake Forest University Health Sciences
Clinicaltrials.gov Identifier
NCT06376916
Other Study ID Numbers:
IRB00110863
First Submitted
April 14, 2024
First Posted
April 21, 2024
Last Update Posted
October 27, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Intravenous magnesium has become a commonly utilized agent in the treatment of cardiac arrhythmias as an adjunct therapy to rate and rhythm control medications, such as its use in atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR). Though its benefit in the treatment of AFF RVR has been well documented, a consensus on the optimal dosing of magnesium has yet to be achieved. Only one randomized, controlled, double-blinded study has investigated the optimal dosing of magnesium.

Condition or DiseaseIntervention/Treatment
Tachycardia AtrialAtrial FibrillationAtrial Flutter With Rapid Ventricular Response
Drug: Magnesium Sulfate 2 GDrug: Magnesium Sulfate 4 GDrug: Saline

Study Design

Study TypeInterventional
Actual Enrollment153 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleAtrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
Study Start DateOctober 6, 2024
Actual Primary Completion Date6mos 1w from now
Actual Study Completion Date6mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Experimental Arm One, Magnesium Sulfate 2g
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)
Drug: Magnesium Sulfate 2 G
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Experimental Arm Two, Magnesium Sulfate 4g
Magnesium Sulfate 4g/50ml 0.9% NaCl
Drug: Magnesium Sulfate 4 G
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Control Arm, normal saline
50ml 0.9% NaCl
Drug: Saline
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Outcome Measures

Primary Outcome Measures
  1. Ventricular rate control
    Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of \< 120 bpm.
Secondary Outcome Measures
  1. Time to achieve goal HR (heart rate)
    Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem
  2. Rate of conversion
    Rate of conversion to normal sinus rhythm (NSR)
  3. Incidence of hypotension
    SBP \< 90 mmHg or MAP (mean arterial pressure) \< 65
  4. Change in heart rate
    Mean change in heart rate up to 24 hours after magnesium infusion
  5. Clinical need for rescue medication administration
    Dose and route of rescue medications given (magnesium and diltiazem)
  6. Adverse effects
    Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Age \> 18 years or older
Able to provide informed consent
Primary diagnosis AFF RVR greater than or equal to 120 bpm
Diltiazem as rate control agent
English speaking
Exclusion Criteria
Hemodynamically unstable patients (SBP \<90, MAP \<65)
Impaired consciousness
End stage renal disease on hemodialysis or peritoneal dialysis
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 AF, such as sick sinus syndrome or wide-complex ventricular response
Acute myocardial infarction
Pregnancy defined as a positive urine HCG (human chorionic gonadotropin)
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

Contacts and Locations

Sponsors and CollaboratorsWake Forest University Health Sciences
Locations
Advocate Christ Medical Center Emergency Department (ACMC ED) | Oak Lawn Illinois, United States, 60453
Investigators
Principal Investigator: Travis Hase, MD, Wake Forest University Health Sciences