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

ConditionsTachycardia AtrialAtrial FibrillationAtrial Flutter With Rapid Ventricular Response
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium Sulfate 2 G

    Drug

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

  • Magnesium Sulfate 4 G

    Drug

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

  • Saline

    Drug

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

Treatment groups

153 Participants
are divided into 3 treatment groups
Group A: Experimental Arm One, Magnesium Sulfate 2gExperimental treatment 1 intervention
Group B: Experimental Arm Two, Magnesium Sulfate 4gExperimental treatment 1 intervention
Group C: Control Arm, normal salinePlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Within the first 2 hours of intravenous magnesium administration

Secondary outcomes

1

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

Time frame
2 hours
2

Rate of conversion

Rate of conversion to normal sinus rhythm (NSR)

Time frame
2 hours after administration of magnesium
3

Incidence of hypotension

SBP \< 90 mmHg or MAP (mean arterial pressure) \< 65

Time frame
At 1 and 2 hours after magnesium administration
4

Change in heart rate

Mean change in heart rate up to 24 hours after magnesium infusion

Time frame
up to 24 hours after magnesium infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov
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