Health TrialsbyHealthPanel

MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation

ConditionAtrial Flutter With Rapid Ventricular Response
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years or older

Able to provide informed consent

Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute

Metoprolol as rate control agent

Disqualifiers

Hemodynamically unstable patients (SBP <90, MAP <65)

Impaired consciousness

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium Sulfate 2g

    Drug

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

  • Magnesium Sulfate 4g

    Drug

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

  • Saline (0.9% NaCl)

    Drug

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

Treatment groups

196 Participants
are divided into 3 treatment groups
Group A: Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mgExperimental treatment 1 intervention
Group B: Experimental Arm Two, Magnesium Sulfate 4g followed by metoprololExperimental treatment 1 intervention
Group C: Control Arm, normal saline followed by metoprololPlacebo 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 beats per minute.

Time frame
Within the first 2 hours of intravenous magnesium administration

Secondary outcomes

1

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
2

Incidence of hypotension

Systolic blood pressure \< 90 or MAP \< 65

Time frame
At 1 and 2 hours after magnesium administration
3

Incidence of bradycardia

Heart rate \< 60 beats per minute

Time frame
At 1 and 2 hours after magnesium administration
4

Mean time to achieve goal heart rate

Mean time to achieve goal heart rate at 2 hours

Time frame
at 2 hours

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

This trial is not recruiting at the moment. You can still explore other options: