NCT07632157

Brief Summary

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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P25-P50 for phase_3

Timeline
30mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2.5 years

First QC Date

May 21, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

AFF RVRintravenous magnesiumatrial flutter

Outcome Measures

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.

    Within the first 2 hours of intravenous magnesium administration

Secondary Outcomes (8)

  • Mean change in heart rate

    up to 24 hours after magnesium infusion

  • Incidence of hypotension

    At 1 and 2 hours after magnesium administration

  • Incidence of bradycardia

    At 1 and 2 hours after magnesium administration

  • Mean time to achieve goal heart rate

    at 2 hours

  • Rate of conversion

    2 hours after administration of magnesium

  • +3 more secondary outcomes

Study Arms (3)

Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg

EXPERIMENTAL

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

Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol

EXPERIMENTAL

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

Control Arm, normal saline followed by metoprolol

PLACEBO COMPARATOR

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)

Interventions

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
Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg

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
Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol

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)
Control Arm, normal saline followed by metoprolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • English speaking

You may not qualify if:

  • 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
  • Rhythms other than atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response
  • Acute myocardial infarction
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Christ Medical Center Emergency Department (ACMC ED)

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Atrial Flutter

Interventions

Magnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Marc McDowell, PharmD

    Advocate Christ Medical Center Emergency Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc McDowell, PharmD

CONTACT

Thomas Szwajnos

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations