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Electrolyte Supplement

Magnesium Sulfate for Rapid Heartbeat (ATRIUM Trial)

Phase 3
Recruiting
Led By Travis Hase, MD
Research Sponsored by Aurora Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diltiazem as rate control agent
Be older than 18 years old
Must not have
End stage renal disease on hemodialysis or peritoneal dialysis
Acute myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 2 hours after magnesium administration
Awards & highlights
Pivotal Trial

Summary

"This trial aims to study the safety and effectiveness of different doses of intravenous magnesium for treating rapid atrial fibrillation."

Who is the study for?
This trial is for individuals with a type of irregular heartbeat known as atrial fibrillation/flutter and rapid heart rate. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.
What is being tested?
The study is testing the effects of two different doses of intravenous magnesium (2g and 4g) compared to a saline placebo in managing atrial fibrillation with a rapid ventricular response. It's set up so neither the patients nor the doctors know who gets which treatment.
What are the potential side effects?
While specific side effects aren't listed, magnesium sulfate can cause flushing, sweating, lowered blood pressure, confusion, muscle weakness and abnormal heart rhythms; saline usually has minimal side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking Diltiazem for heart rate control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis for end-stage kidney disease.
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I have had a heart attack recently.
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I am not allergic to the drugs used in this study.
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My blood pressure is stable and not too low.
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I have been diagnosed with a worsening of heart failure recently.
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My heart rhythm issue is not atrial fibrillation but another type like sick sinus syndrome.
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I do not have conditions like myasthenia gravis that make magnesium sulfate unsafe for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 hours after magnesium administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 2 hours after magnesium administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ventricular rate control
Secondary study objectives
Adverse effects
Change in heart rate
Clinical need for rescue medication administration
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental Arm Two, Magnesium Sulfate 4gExperimental Treatment1 Intervention
Magnesium Sulfate 4g/50ml 0.9% NaCl
Group II: Experimental Arm One, Magnesium Sulfate 2gExperimental Treatment1 Intervention
Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)
Group III: Control Arm, normal salinePlacebo Group1 Intervention
50ml 0.9% NaCl

Find a Location

Who is running the clinical trial?

Aurora Health CareLead Sponsor
45 Previous Clinical Trials
16,265 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
201 Patients Enrolled for Atrial Fibrillation
Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,052 Total Patients Enrolled
7 Trials studying Atrial Fibrillation
506 Patients Enrolled for Atrial Fibrillation
Travis Hase, MDPrincipal InvestigatorWake Forest University Health Sciences
~102 spots leftby Dec 2025
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