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

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 3

Conditions: Atrial Fibrillation; Tachycardia Atrial; Atrial Flutter With Rapid Ventricular Response

Treatments: Drug: Magnesium Sulfate 4 G; Drug: Magnesium Sulfate 2 G; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06376916

IRB00110863

Details and patient eligibility

About

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.

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.

Enrollment: 153 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

153 participants in 3 patient groups, including a placebo group

Experimental Arm One, Magnesium Sulfate 2g

Experimental group

Description:

Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)

Treatment:

Drug: Magnesium Sulfate 2 G

Experimental Arm Two, Magnesium Sulfate 4g

Experimental group

Description:

Magnesium Sulfate 4g/50ml 0.9% NaCl

Treatment:

Drug: Magnesium Sulfate 4 G

Control Arm, normal saline

Placebo Comparator group

Description:

50ml 0.9% NaCl

Treatment:

Drug: Saline