Clinical trial NCT06376916: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Tachycardia Atrial
Atrial Fibrillation
Atrial Flutter With Rapid Ventricular Response
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Ventricular rate control
timeFrame: Within the first 2 hours of intravenous magnesium administration
Secondary outcomes:
measure: Time to achieve goal HR (heart rate)
timeFrame: 2 hours
measure: Rate of conversion
timeFrame: 2 hours after administration of magnesium
measure: Incidence of hypotension
timeFrame: At 1 and 2 hours after magnesium administration
measure: Change in heart rate
timeFrame: up to 24 hours after magnesium infusion
measure: Clinical need for rescue medication administration
timeFrame: 2 hours from diltiazem administration
measure: Adverse effects
timeFrame: 2 hours from diltiazem administration
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center Emergency Department (ACMC ED)
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: Travis Hase, MD
role: PRINCIPAL_INVESTIGATOR
References: