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

Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR

The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Tachycardia Atrial; Atrial Flutter With Rapid Ventricular Response
• Intervention / Treatment: Drug: Magnesium Sulfate 2 G; Drug: Magnesium Sulfate 4 G; Drug: Saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marc McDowell, PharmD; Phone Number: (708) 684-1078; Email: marc.mcdowell@aah.org

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Recruiting
      • Advocate Christ Medical Center Emergency Department (ACMC ED)
      • Contact: Marc McDowell, PharmD; Phone Number: 708-684-6230; Email: marc.mcdowell@aah.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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); Other Names: Magnesium Sulfate 2 gram/50ml 0.9% NaCl
Experimental: 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); Other Names: Magnesium Sulfate 4g/50ml 0.9% NaCl
Placebo Comparator: 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.; Other Names: Control (50ml 0.9% NaCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within the first 2 hours of intravenous magnesium administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 hours
Rate of conversion	Rate of conversion to normal sinus rhythm (NSR)	2 hours after administration of magnesium
Incidence of hypotension	SBP < 90 mmHg or MAP (mean arterial pressure) < 65	At 1 and 2 hours after magnesium administration
Change in heart rate	Mean change in heart rate up to 24 hours after magnesium infusion	up to 24 hours after magnesium infusion
Adverse effects	Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)	2 hours from diltiazem administration
Clinical need for rescue medication administration	Dose and route of rescue medications given (magnesium and diltiazem)	2 hours from diltiazem administration

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Travis Hase, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 28, 2025
• Last Update Submitted That Met QC Criteria: October 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; 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: IRB00110863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No