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

Atrial Fibrillation Clinical Trial

— ATRIUM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06376916
• Other study ID #: IRB00110863
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Aurora Health Care
• Contact: Marc McDowell, PharmD
• Phone: (708) 684-1078
• Email: marc.mcdowell[@]aah.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Tachycardia
• Tachycardia Atrial

Intervention

Drug:
• Magnesium Sulfate 2 G
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
• Magnesium Sulfate 4 G
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
• Saline
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center Emergency Department (ACMC ED)	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of conversion	Rate of conversion to normal sinus rhythm (NSR)	2 hours after administration of magnesium
Secondary	Incidence of hypotension	SBP < 90 mmHg or MAP (mean arterial pressure) < 65	At 1 and 2 hours after magnesium administration
Secondary	Change in heart rate	Mean change in heart rate up to 24 hours after magnesium infusion	up to 24 hours after magnesium infusion
Secondary	Clinical need for rescue medication administration	Dose and route of rescue medications given (magnesium and diltiazem)	2 hours from diltiazem administration
Secondary	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