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RecruitingNCT06376916ATRIUMUpdated Sep 28, 2026

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Tachycardia Atrial
  • Atrial Fibrillation
  • Atrial Flutter With Rapid Ventricular Response

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
153 participants (estimated)

Study arms

  • Experimental
    Experimental Arm One, Magnesium Sulfate 2g

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

    Drug: Magnesium Sulfate 2 G

  • Experimental
    Experimental Arm Two, Magnesium Sulfate 4g

    Magnesium Sulfate 4g/50ml 0.9% NaCl

    Drug: Magnesium Sulfate 4 G

  • Placebo comparator
    Control Arm, normal saline

    50ml 0.9% NaCl

    Drug: Saline

Interventions

  • DrugMagnesium Sulfate 2 G

    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

  • DrugMagnesium Sulfate 4 G

    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

  • DrugSaline

    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)

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Rate of conversion

    Rate of conversion to normal sinus rhythm (NSR)

    Time frame: 2 hours after administration of magnesium

  3. Incidence of hypotension

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

    Time frame: At 1 and 2 hours after magnesium administration

  4. 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

  5. Clinical need for rescue medication administration

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

    Time frame: 2 hours from diltiazem administration

  6. 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

06

Study locations

1 of 1 sites recruiting
  • Advocate Christ Medical Center Emergency Department (ACMC ED)
    Oak Lawn, Illinois 60453, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06376916
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Oct 7, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 28, 2026

Study contacts

Marc McDowell, PharmD
Contact
marc.mcdowell@aah.org
(708) 684-1078
Travis Hase, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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