Recruiting
Phase 3

Magnesium

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06376916

Conditions

Tachycardia Atrial

Atrial Fibrillation

Atrial Flutter With Rapid Ventricular Response

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium Sulfate 2 G

Magnesium Sulfate 4 G

Saline

Study Details

Brief 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.

Conditions

Tachycardia Atrial

Atrial Fibrillation

Atrial Flutter With Rapid Ventricular Response

Study ID

NCT06376916

Start date

Oct 7, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

153 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Arm One, Magnesium Sulfate 2g

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

experimental: Experimental Arm Two, Magnesium Sulfate 4g

Magnesium Sulfate 4g/50ml 0.9% NaCl

placebo comparator: Control Arm, normal saline

50ml 0.9% NaCl

Interventions

Magnesium Sulfate 2 G

Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Magnesium Sulfate 4 G

Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)

Saline

The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Primary outcome measure

  • Ventricular rate control [ Time Frame: Within the first 2 hours of intravenous magnesium administration ]

Central Contacts and Locations

Central contacts

Marc McDowell, PharmD

(708) 684-1078marc.mcdowell@aah.org

Locations

Advocate Christ Medical Center Emergency Department (ACMC ED)

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Marc McDowell, PharmD

708-684-6230marc.mcdowell@aah.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 28, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-10-28.