A Phase 3 interventional study of Magnesium Sulfate 2 G and Magnesium Sulfate 4 G in Tachycardia Atrial, Atrial Fibrillation and Atrial Flutter With Rapid Ventricular Response, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Wake Forest University Health Sciences · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)
Drug: Magnesium Sulfate 2 G
Magnesium Sulfate 4g/50ml 0.9% NaCl
Drug: Magnesium Sulfate 4 G
50ml 0.9% NaCl
Drug: Saline
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Also known as: Magnesium Sulfate 2 gram/50ml 0.9% NaCl
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Also known as: Magnesium Sulfate 4g/50ml 0.9% NaCl
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
Also known as: Control (50ml 0.9% NaCl)
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.
Time frame: Within the first 2 hours of intravenous magnesium administration
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
Time frame: 2 hours
Rate of conversion
Rate of conversion to normal sinus rhythm (NSR)
Time frame: 2 hours after administration of magnesium
Incidence of hypotension
SBP \< 90 mmHg or MAP (mean arterial pressure) \< 65
Time frame: At 1 and 2 hours after magnesium administration
Change in heart rate
Mean change in heart rate up to 24 hours after magnesium infusion
Time frame: up to 24 hours after magnesium infusion
Clinical need for rescue medication administration
Dose and route of rescue medications given (magnesium and diltiazem)
Time frame: 2 hours from diltiazem administration
Adverse effects
Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)
Time frame: 2 hours from diltiazem administration
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Wake Forest University Health Sciences