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

• ClinicalTrials.gov Identifier: NCT06376916
• Recruitment Status: Not yet recruiting
• First Posted: April 22, 2024
• Last Update Posted: April 24, 2024
• Sponsor: Aurora Health Care
• Information provided by (Responsible Party): Travis Hase, Aurora Health Care

Tracking Information

• First Submitted Date: April 15, 2024
• First Posted Date: April 22, 2024
• Last Update Posted Date: April 24, 2024
• Estimated Study Start Date: April 2024
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2024)

Ventricular rate control [ Time Frame: Within the first 2 hours of intravenous magnesium administration ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 22, 2024)

• Time to achieve goal HR (heart rate) [ Time Frame: 2 hours ]
  Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem
• Rate of conversion [ Time Frame: 2 hours after administration of magnesium ]
  Rate of conversion to normal sinus rhythm (NSR)
• Incidence of hypotension [ Time Frame: At 1 and 2 hours after magnesium administration ]
  SBP < 90 mmHg or MAP (mean arterial pressure) < 65
• Change in heart rate [ Time Frame: up to 24 hours after magnesium infusion ]
  Mean change in heart rate up to 24 hours after magnesium infusion
• Clinical need for rescue medication administration [ Time Frame: 2 hours from diltiazem administration ]
  Dose and route of rescue medications given (magnesium and diltiazem)
• Adverse effects [ Time Frame: 2 hours from diltiazem administration ]
  Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)

Original Secondary Outcome Measures (submitted: April 15, 2024)

• Time to achieve goal HR (heart rate) [ Time Frame: 2 hours ]
  Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem
• Rate of conversion [ Time Frame: 2 hours after administration of magnesium ]
  Rate of conversion to normal sinus rhythm (NSR)
• Incidence of hypotension [ Time Frame: At 1 and 2 hours after magnesium administration ]
  SBP < 90 mmHg or MAP (mean arterial pressure) < 65
• Change in heart rate [ Time Frame: up to 24 hours after magnesium infusion ]
  Mean change in heart rate up to 24 hours after magnesium infusion
• Rescue medication [ Time Frame: 2 hours from diltiazem administration ]
  Clinical need for rescue medication administration
• Adverse effects [ Time Frame: 2 hours from diltiazem administration ]
  Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: Magnesium Sulfate 2 G
  Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  Other Name: Magnesium Sulfate 2 gram/50ml 0.9% NaCl
• Drug: Magnesium Sulfate 4 G
  Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
  Other Name: Magnesium Sulfate 4g/50ml 0.9% NaCl
• Drug: Saline
  The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
  Other Name: Control (50ml 0.9% NaCl)

Study Arms

• Experimental: Experimental Arm One, Magnesium Sulfate 2g
  Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)
  Intervention: Drug: Magnesium Sulfate 2 G
• Experimental: Experimental Arm Two, Magnesium Sulfate 4g
  Magnesium Sulfate 4g/50ml 0.9% NaCl
  Intervention: Drug: Magnesium Sulfate 4 G
• Placebo Comparator: Control Arm, normal saline
  50ml 0.9% NaCl
  Intervention: Drug: Saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 15, 2024): 153
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2026
• Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Marc McDowell, PharmD; (708) 684-1078; marc.mcdowell@aah.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06376916
• Other Study ID Numbers: IRB00110863
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Travis Hase, Aurora Health Care
• Original Responsible Party: Travis Hase, Aurora Health Care, MD
• Current Study Sponsor: Aurora Health Care
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Travis Hase, MD; Aurora Health Care

• PRS Account: Aurora Health Care
• Verification Date: April 2024