ClinicalTrials.gg
RecruitingNCT06376916ATRIUMUpdated Sep 28, 2026

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

A Phase 3 interventional study of Magnesium Sulfate 2 G and Magnesium Sulfate 4 G in Tachycardia Atrial, Atrial Fibrillation and Atrial Flutter With Rapid Ventricular Response, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Wake Forest University Health Sciences · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years 1 month later.

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Phase
Phase 3
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 993 studies in Atrial Fibrillation with a site in United States — 161 open to participants now, 220 under way, 15 of them phase 3. Atrial Fibrillation · United States.

Planned enrollment
306th of 679
153 · median 127
Started
2024
with 53 others
Phase 3
100 of 993
11 open now
Primary completion
2026-12
later than 67 of 219 live
Registered
881st of 993
by date

Among the 993 studies in Atrial Fibrillation with a site in United States, this one is the 306th largest by planned enrollment of the 679 interventional ones that give a count, is one of 54 that started in 2024, is one of 100 in phase 3, reaches primary completion later than 67 of the 219 other live ones, and was the 881st registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

161 of the 993 studies in Atrial Fibrillation with a site in United States are open now. Recruiting first, the newest first:

156 more — sign in →

All 161 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed 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.

03

Conditions studied

  • Tachycardia Atrial
  • Atrial Fibrillation
  • Atrial Flutter With Rapid Ventricular Response

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Age > 18 years or older
  • Able to provide
  • Primary diagnosis AFF RVR greater than or equal to 120 bpm
  • Diltiazem as rate control agent
  • English speaking

Exclusion criteria

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)
  • 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
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
153 participants (estimated)

Study arms

  • Experimental
    Experimental Arm One, Magnesium Sulfate 2g

    Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)

    Drug: Magnesium Sulfate 2 G

  • Experimental
    Experimental Arm Two, Magnesium Sulfate 4g

    Magnesium Sulfate 4g/50ml 0.9% NaCl

    Drug: Magnesium Sulfate 4 G

  • Placebo comparator
    Control Arm, normal saline

    50ml 0.9% NaCl

    Drug: Saline

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

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

    Also known as: Magnesium Sulfate 4g/50ml 0.9% NaCl

  • DrugSaline

    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)

06

What researchers measure

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

  5. Clinical need for rescue medication administration

    Dose and route of rescue medications given (magnesium and diltiazem)

    Time frame: 2 hours from diltiazem administration

  6. Adverse effects

    Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)

    Time frame: 2 hours from diltiazem administration

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.

Of 62 non-industry phase 3 interventional studies under Atrial Fibrillation, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 73. This study's planned 26 months is below that.

Counting every sponsor, half of 83 studies reached it within 42 months; a quarter within 32 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 15, 2024
First posted
Apr 22, 2024
StartActual
Oct 7, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06376916
Responsible party
Sponsor
First posted
Apr 22, 2024
Start date
Oct 7, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 28, 2026

Study contacts

Marc McDowell, PharmD
Contact
marc.mcdowell@aah.org
(708) 684-1078
Travis Hase, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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