MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)

Wake Forest University (WFU)

Status and phase: Not yet enrolling; Phase 3

Conditions: Atrial Flutter With Rapid Ventricular Response

Treatments: Drug: Saline (0.9% NaCl); Drug: Magnesium Sulfate 4g; Drug: Magnesium Sulfate 2g

Study type: Interventional

Funder types: Other

Identifiers

NCT07632157

IRB00146620

Details and patient eligibility

About

The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).

Full 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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 3 patient groups, including a placebo group

Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg

Experimental group

Description:

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.

Treatment:

Drug: Magnesium Sulfate 2g

Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol

Experimental group

Description:

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.

Treatment:

Drug: Magnesium Sulfate 4g

Control Arm, normal saline followed by metoprolol

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline (0.9% NaCl)