Tachycardia AtrialPhase 3ATRIUMNCT06376916
Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
A Phase 3 study testing Magnesium Sulfate 2 G, Magnesium Sulfate 4 G and Saline in people with Tachycardia Atrial and Atrial Fibrillation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia Atrial, Atrial Fibrillation, Atrial Flutter With Rapid Ventricular Response
- What is being tested?
- Magnesium Sulfate 2 G, Magnesium Sulfate 4 G and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- English speaking
Who cannot join
- 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
Show all 12Show fewer
- Acute myocardial infarction
- Pregnancy defined as a positive urine HCG (human chorionic gonadotropin)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Advocate Christ Medical Center Emergency Department (ACMC ED)
Oak Lawn, Illinois, 60453
Marc McDowell, PharmD, 708-684-6230, marc.mcdowell@aah.org
About this study
Official title: Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
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.
- Being tested
- Magnesium Sulfate 2 G, Magnesium Sulfate 4 G, Saline
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 2 GDrug
Also called Magnesium Sulfate 2 gram/50ml 0.9% NaCl
Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
Magnesium Sulfate 4 GDrug
Also called Magnesium Sulfate 4g/50ml 0.9% NaCl
Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)
SalineDrug
Also called Control (50ml 0.9% NaCl)
The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm One, Magnesium Sulfate 2g | Experimental | Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) Receives: Drug: Magnesium Sulfate 2 G |
| Experimental Arm Two, Magnesium Sulfate 4g | Experimental | Magnesium Sulfate 4g/50ml 0.9% NaCl Receives: Drug: Magnesium Sulfate 4 G |
| Control Arm, normal saline | Placebo comparator | 50ml 0.9% NaCl Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 2 hours of intravenous magnesium administration
Secondary outcomes (6)
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
Measured: 2 hours
Rate of conversion
Rate of conversion to normal sinus rhythm (NSR)
Measured: 2 hours after administration of magnesium
Incidence of hypotension
SBP < 90 mmHg or MAP (mean arterial pressure) < 65
Measured: At 1 and 2 hours after magnesium administration
Change in heart rate
Mean change in heart rate up to 24 hours after magnesium infusion
Measured: up to 24 hours after magnesium infusion
Clinical need for rescue medication administration
Dose and route of rescue medications given (magnesium and diltiazem)
Measured: 2 hours from diltiazem administration
Adverse effects
Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)
Measured: 2 hours from diltiazem administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start7 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia AtrialStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Travis Hase, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376916
- Sponsor's protocol ID
- IRB00110863
- Acronym
- ATRIUM
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
- ClinicalTrials.gov ID
- NCT06376916
- Acronym / sponsor ID
- ATRIUM / IRB00110863
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm One, Magnesium Sulfate 2g | Experimental | Drug: Magnesium Sulfate 2 GStudy drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl) |
| Experimental Arm Two, Magnesium Sulfate 4g | Experimental | Drug: Magnesium Sulfate 4 GMagnesium Sulfate 4g/50ml 0.9% NaCl |
| Control Arm, normal saline | Placebo comparator | Drug: Saline50ml 0.9% NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- English speaking
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate 2 GAlso: Magnesium Sulfate 2 gram/50ml 0.9% NaClMagnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) | Drug | Experimental Arm One, Magnesium Sulfate 2g |
| Magnesium Sulfate 4 GAlso: Magnesium Sulfate 4g/50ml 0.9% NaClMagnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) | Drug | Experimental Arm Two, Magnesium Sulfate 4g |
| SalineAlso: Control (50ml 0.9% NaCl)The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes. | Drug | Control Arm, normal saline |
Primary outcome
Ventricular rate control
Time frame: Within the first 2 hours of intravenous magnesium administration
Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of < 120 bpm.
6 secondary outcomes
Time to achieve goal HR (heart rate)
Time frame: 2 hours
Rate of conversion
Time frame: 2 hours after administration of magnesium
Incidence of hypotension
Time frame: At 1 and 2 hours after magnesium administration
Change in heart rate
Time frame: up to 24 hours after magnesium infusion
Clinical need for rescue medication administration
Time frame: 2 hours from diltiazem administration
Adverse effects
Time frame: 2 hours from diltiazem administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Tachycardia Atrial
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Not yet recruitingObservational study
Conduction Breakthrough in the Coronary Sinus Post Endocardial Mitral Isthmus Ablation
Atrial Fibrillation (AF), Atrial Tachycardia
Not yet recruiting
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
RecruitingObservational study
The Multicenter Cardiology Monitoring Platform Registry
Heart Failure, Cardiomyopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Travis Hase, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Sulfate 2 G, Magnesium Sulfate 4 G and Saline in people with Tachycardia Atrial and Atrial Fibrillation, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc McDowell, PharmD ((708) 684-1078, marc.mcdowell@aah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular rate control (time frame: Within the first 2 hours of intravenous magnesium administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.