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Not yet recruiting NCT07632157

MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation

Phase III Interventional 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 2g, Magnesium Sulfate 4g, Saline (0.9% NaCl).
Who it may be relevant to
Registry conditions: 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 →
Official title

MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)

Overview

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).

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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.

Interventions

  • Drug Magnesium Sulfate 2g
    Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  • Drug Magnesium Sulfate 4g
    Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  • Drug 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 measures

  • Ventricular rate control [Time frame: Within the first 2 hours of intravenous magnesium administration]
Secondary outcome measures (8)
  • Mean change in heart rate [Time frame: up to 24 hours after magnesium infusion]
  • Incidence of hypotension [Time frame: At 1 and 2 hours after magnesium administration]
  • Incidence of bradycardia [Time frame: At 1 and 2 hours after magnesium administration]
  • Mean time to achieve goal heart rate [Time frame: at 2 hours]
  • Rate of conversion [Time frame: 2 hours after administration of magnesium]
  • Clinical need for rescue medication administration [Time frame: 2 hours from metoprolol administration]
  • Mean change in heart rhythm [Time frame: up to 24 hours after magnesium infusion]
  • Clinical need for rescue medication administration [Time frame: 2 hours from metoprolol administration]

Eligibility criteria

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

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: NCT07632157 · IRB00146620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗