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NCT Number: NCT06376916

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advocate Christ Medical Center Emergency Department (ACMC ED)

Oak Lawn, Illinois, 60453, United States

Location status: Recruiting

Location contact

Marc McDowell, PharmD

CONTACT

[email protected]

708-684-6230

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium Sulfate 2 G

Drug

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

Magnesium Sulfate 4 G

Drug

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

Saline

Drug

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)

Primary outcomes

  1. Ventricular rate control

    Time frame: Within the first 2 hours of intravenous magnesium administration

    Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of < 120 bpm.

Secondary outcomes

  1. Time to achieve goal HR (heart rate)

    Time frame: 2 hours

    Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem

  2. Rate of conversion

    Time frame: 2 hours after administration of magnesium

    Rate of conversion to normal sinus rhythm (NSR)

  3. Incidence of hypotension

    Time frame: At 1 and 2 hours after magnesium administration

    SBP < 90 mmHg or MAP (mean arterial pressure) < 65

  4. Change in heart rate

    Time frame: up to 24 hours after magnesium infusion

    Mean change in heart rate up to 24 hours after magnesium infusion

  5. Clinical need for rescue medication administration

    Time frame: 2 hours from diltiazem administration

    Dose and route of rescue medications given (magnesium and diltiazem)

  6. Adverse effects

    Time frame: 2 hours from diltiazem administration

    Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)

Study contacts

Contact information is provided by the study sponsor or research team.

Marc McDowell, PharmD

CONTACT

[email protected]

(708) 684-1078

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Acronym: ATRIUM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2024
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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