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Recruiting NCT06376916

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

Phase III Interventional Tachycardia Atrial Atrial Fibrillation Atrial Flutter With Rapid Ventricular Response

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium Sulfate 2 G, Magnesium Sulfate 4 G, Saline.
Who it may be relevant to
Registry conditions: Tachycardia Atrial, Atrial Fibrillation, Atrial Flutter With Rapid Ventricular Response. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

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.

Interventions

  • Drug Magnesium Sulfate 2 G
    Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  • Drug Magnesium Sulfate 4 G
    Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  • Drug Saline
    The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Primary outcome measures

  • Ventricular rate control [Time frame: Within the first 2 hours of intravenous magnesium administration]
Secondary outcome measures (6)
  • Time to achieve goal HR (heart rate) [Time frame: 2 hours]
  • Rate of conversion [Time frame: 2 hours after administration of magnesium]
  • Incidence of hypotension [Time frame: At 1 and 2 hours after magnesium administration]
  • Change in heart rate [Time frame: up to 24 hours after magnesium infusion]
  • Clinical need for rescue medication administration [Time frame: 2 hours from diltiazem administration]
  • Adverse effects [Time frame: 2 hours from diltiazem administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Advocate Christ Medical Center Emergency Department (ACMC ED) — Oak Lawn

Identifiers

NCT: NCT06376916 · IRB00110863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗