Recruiting
Phase 3

Magnesium with Metoprolol

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07632157

Conditions

Atrial Flutter With Rapid Ventricular Response

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium Sulfate 2g

Magnesium Sulfate 4g

Saline (0.9% NaCl)

Study Details

Brief summary:

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).

Conditions

Atrial Flutter With Rapid Ventricular Response

Study ID

NCT07632157

Start date

Nov 10, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

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 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

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

experimental: Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol

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.

placebo comparator: Control Arm, normal saline followed by metoprolol

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.

Interventions

Magnesium Sulfate 2g

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

Magnesium Sulfate 4g

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

Saline (0.9% NaCl)

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

Thomas Szwajnos

Thomas.Szwajnos@aah.org

Locations

Advocate Christ Medical Center Emergency Department (ACMC ED)

Recruiting

Oak Lawn, Illinois, United States, 60453

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • AFF RVR
  • intravenous magnesium
  • atrial flutter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.