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

Last updated: November 13, 2024
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Atrial Fibrillation

Atrial Flutter

Heart Disease

Treatment

Magnesium Sulfate 2 G

Saline

Magnesium Sulfate 4 G

Clinical Study ID

NCT06376916
IRB00110863
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

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 analternative clinical diagnosis

  • Rhythms other than AF, such as sick sinus syndrome or wide-complex ventricularresponse

  • 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

Total Participants: 153
Treatment Group(s): 3
Primary Treatment: Magnesium Sulfate 2 G
Phase: 3
Study Start date:
October 07, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Advocate Christ Medical Center Emergency Department (ACMC ED)

    Oak Lawn, Illinois 60453
    United States

    Active - Recruiting

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