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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06376916
Other study ID # IRB00110863
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 2024
Est. completion date December 2026

Study information

Verified date June 2024
Source Aurora Health Care
Contact Marc McDowell, PharmD
Phone (708) 684-1078
Email marc.mcdowell@aah.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 153
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Magnesium Sulfate 2 G
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Magnesium Sulfate 4 G
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Saline
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.

Locations

Country Name City State
United States Advocate Christ Medical Center Emergency Department (ACMC ED) Oak Lawn Illinois

Sponsors (1)

Lead Sponsor Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

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