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

NCT06376916 | Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB00110863
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia Atrial; Atrial Fibrillation; Atrial Flutter With Rapid Ventricular Response

Outcome Measures

Primary Outcomes (1)

• Ventricular rate control

  Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of \< 120 bpm.

  Within the first 2 hours of intravenous magnesium administration

Secondary Outcomes (6)

• Time to achieve goal HR (heart rate)

  2 hours

• Rate of conversion

  2 hours after administration of magnesium

• Incidence of hypotension

  At 1 and 2 hours after magnesium administration

• Change in heart rate

  up to 24 hours after magnesium infusion

• Clinical need for rescue medication administration

  2 hours from diltiazem administration

Study Arms (3)

Experimental Arm One, Magnesium Sulfate 2g

EXPERIMENTAL

Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)

Drug: Magnesium Sulfate 2 G

Experimental Arm Two, Magnesium Sulfate 4g

EXPERIMENTAL

Magnesium Sulfate 4g/50ml 0.9% NaCl

Drug: Magnesium Sulfate 4 G

Control Arm, normal saline

PLACEBO COMPARATOR

50ml 0.9% NaCl

Drug: Saline

Interventions

Magnesium Sulfate 2 G DRUG

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

Also known as: Magnesium Sulfate 2 gram/50ml 0.9% NaCl

Experimental Arm One, Magnesium Sulfate 2g

Magnesium Sulfate 4 G DRUG

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

Also known as: Magnesium Sulfate 4g/50ml 0.9% NaCl

Experimental Arm Two, Magnesium Sulfate 4g

Saline DRUG

The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Also known as: Control (50ml 0.9% NaCl)

Control Arm, normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Christ Medical Center Emergency Department (ACMC ED)

Oak Lawn, Illinois, 60453, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnesium Sulfate; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Travis Hase, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc McDowell, PharmD

CONTACT

(708) 684-1078; marc.mcdowell@aah.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 22, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Locations

US (1)