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ATRIUM: Magnesium 2g vs 4g vs Placebo for AFF RVR
NCT06376916Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Wake Forest University Health Sciences
- Modality
- Small Molecules
- Drugs
- magnesium sulfate
- Conditions
- Atrial fibrillation (AFib)atrial flutter (AFL)atrial tachycardia (AT)
01
Overview
Phase 3, randomised, double-blind trial of magnesium sulfate in Atrial fibrillation (AFib), atrial flutter (AFL) and atrial tachycardia (AT) (3 arms), sponsored by Wake Forest University Health Sciences. Primary endpoint: Ventricular rate control at 2 hours. Started Oct 2024; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Magnesium Sulfate 2g
Magnesium Sulfate 2g/50ml 0.9% NaCl IV bolus over 15 minutes + Diltiazem
Magnesium Sulfate 4g
Magnesium Sulfate 4g/50ml 0.9% NaCl IV bolus over 15 minutes + Diltiazem
Placebo (Normal Saline)
50ml 0.9% NaCl IV bolus over 15 minutes + Diltiazem
03
Who it enrols
Adults with a primary diagnosis of AFF RVR >= 120 bpm receiving diltiazem, excluding those who are hemodynamically unstable, pregnant, or have acute heart failure, acute MI, or ESRD on dialysis.
04
Endpoints
Primary
Ventricular rate control
Secondary
Time to achieve goal heart rate
Rate of conversion
Incidence of hypotension
Change in heart rate
Clinical need for rescue medication administration
Adverse effects
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