A Phase 3 interventional study of Magnesium Sulfate 2g and Magnesium Sulfate 4g in Atrial Flutter With Rapid Ventricular Response, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Wake Forest University Health Sciences · Phase 3, Interventional, and Treatment
The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).
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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.
223 studies on the registry are indexed under Atrial Flutter; 51 are open to participants now.
This study's planned enrollment of 196 is above the median of 150 across 155 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes. Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
Drug: Magnesium Sulfate 2g
Study drug (Magnesium Sulfate 4 gram/50ml 0.9% NaCl) will be administered over a time interval of 15 minutes. Immediately after study drug administration, intravenous metoprolol 5 mg will be administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of study drug will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
Drug: Magnesium Sulfate 4g
50ml 0.9% NaCl will be administered over a time interval of 15 minutes. Intravenous metoprolol 5 mg will be immediately administered as an IV push over 2 minutes. Additional doses of metoprolol 5 mg as an IV push over 1 minute permissible, however additional doses of saline will not be administered. Emergency Medicine physician may provide additional doses of intravenous metoprolol every 5 minutes based on clinical necessity.
Drug: Saline (0.9% NaCl)
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
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Also known as: Magnesium Sulfate 4 gram/50ml 0.9% NaCl
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)
Ventricular rate control
Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of \< 120 beats per minute.
Time frame: Within the first 2 hours of intravenous magnesium administration
Mean change in heart rate
Mean change in heart rate after the administration of magnesium sulfate
Time frame: up to 24 hours after magnesium infusion
Incidence of hypotension
Systolic blood pressure \< 90 or MAP \< 65
Time frame: At 1 and 2 hours after magnesium administration
Incidence of bradycardia
Heart rate \< 60 beats per minute
Time frame: At 1 and 2 hours after magnesium administration
Mean time to achieve goal heart rate
Mean time to achieve goal heart rate at 2 hours
Time frame: at 2 hours
Rate of conversion
Rate of conversion to normal sinus rhythm
Time frame: 2 hours after administration of magnesium
Clinical need for rescue medication administration
Dose of rescue medications given (magnesium and metoprolol)
Time frame: 2 hours from metoprolol administration
Mean change in heart rhythm
Mean change in heart rhythm after the administration of magnesium sulfate
Time frame: up to 24 hours after magnesium infusion
Clinical need for rescue medication administration
Route of administration (IV or PO) for rescue medications (magnesium and metoprolol), if administered.
Time frame: 2 hours from metoprolol administration
Plan to share: No
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Studies of the drug tested here: Magnesium Sulfate
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