Clinical trial

Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR

Name

IRB00110863

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-12-01

Trial end

2026-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Magnesium Sulfate 2 G

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

Arms:

Experimental Arm One, Magnesium Sulfate 2g

Other names:

Magnesium Sulfate 2 gram/50ml 0.9% NaCl

Magnesium Sulfate 4 G

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

Arms:

Experimental Arm Two, Magnesium Sulfate 4g

Other names:

Magnesium Sulfate 4g/50ml 0.9% NaCl

Saline

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

Arms:

Control Arm, normal saline

Other names:

Control (50ml 0.9% NaCl)

Size

153

Primary endpoint

Ventricular rate control

Within the first 2 hours of intravenous magnesium administration

Eligibility criteria

Inclusion Criteria: * 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 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) * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 153, 'type': 'ESTIMATED'}}

Updated at

2024-06-06

1 organization

1 product

1 drug

3 indications

Organization

Product

Indication

Indication

Indication

Drug