Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT06376916
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2024-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-25', 'studyFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular rate control', 'timeFrame': 'Within the first 2 hours of intravenous magnesium administration', 'description': 'Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of \\< 120 bpm.'}], 'secondaryOutcomes': [{'measure': 'Time to achieve goal HR (heart rate)', 'timeFrame': '2 hours', 'description': 'Mean change in heart rate and rhythm after the administration of magnesium sulfate as well as after the administration of diltiazem'}, {'measure': 'Rate of conversion', 'timeFrame': '2 hours after administration of magnesium', 'description': 'Rate of conversion to normal sinus rhythm (NSR)'}, {'measure': 'Incidence of hypotension', 'timeFrame': 'At 1 and 2 hours after magnesium administration', 'description': 'SBP \\< 90 mmHg or MAP (mean arterial pressure) \\< 65'}, {'measure': 'Change in heart rate', 'timeFrame': 'up to 24 hours after magnesium infusion', 'description': 'Mean change in heart rate up to 24 hours after magnesium infusion'}, {'measure': 'Clinical need for rescue medication administration', 'timeFrame': '2 hours from diltiazem administration', 'description': 'Dose and route of rescue medications given (magnesium and diltiazem)'}, {'measure': 'Adverse effects', 'timeFrame': '2 hours from diltiazem administration', 'description': 'Patient reported adverse effects (e.g.. flushing, headache, nausea, new onset or worsening lightheadedness since beginning the magnesium infusion)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tachycardia Atrial', 'Atrial Fibrillation', 'Atrial Flutter With Rapid Ventricular Response']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years or older\n* Able to provide informed consent\n* Primary diagnosis AFF RVR greater than or equal to 120 bpm\n* Diltiazem as rate control agent\n* English speaking\n\nExclusion Criteria:\n\n* Hemodynamically unstable patients (SBP \\<90, MAP \\<65)\n* Impaired consciousness\n* End stage renal disease on hemodialysis or peritoneal dialysis\n* Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and/or additional imaging\n* Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis\n* Rhythms other than AF, such as sick sinus syndrome or wide-complex ventricular response\n* Acute myocardial infarction\n* Pregnancy defined as a positive urine HCG (human chorionic gonadotropin)\n* Contraindications to magnesium sulfate (including myasthenia gravis)\n* Allergy or sensitivity to any study drugs\n* Previously enrolled in this trial during a different patient encounter\n* Withdrew from study'}, 'identificationModule': {'nctId': 'NCT06376916', 'acronym': 'ATRIUM', 'briefTitle': 'Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Atrial Tachycardia Reduction With Intravenous Use of Magnesium (ATRIUM) Study: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR', 'orgStudyIdInfo': {'id': 'IRB00110863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm One, Magnesium Sulfate 2g', 'description': 'Study drug (Magnesium Sulfate 2 gram/50ml 0.9% NaCl)', 'interventionNames': ['Drug: Magnesium Sulfate 2 G']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Arm Two, Magnesium Sulfate 4g', 'description': 'Magnesium Sulfate 4g/50ml 0.9% NaCl', 'interventionNames': ['Drug: Magnesium Sulfate 4 G']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm, normal saline', 'description': '50ml 0.9% NaCl', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Magnesium Sulfate 2 G', 'type': 'DRUG', 'otherNames': ['Magnesium Sulfate 2 gram/50ml 0.9% NaCl'], 'description': 'Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)', 'armGroupLabels': ['Experimental Arm One, Magnesium Sulfate 2g']}, {'name': 'Magnesium Sulfate 4 G', 'type': 'DRUG', 'otherNames': ['Magnesium Sulfate 4g/50ml 0.9% NaCl'], 'description': 'Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)', 'armGroupLabels': ['Experimental Arm Two, Magnesium Sulfate 4g']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Control (50ml 0.9% NaCl)'], 'description': 'The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.', 'armGroupLabels': ['Control Arm, normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc McDowell, PharmD', 'role': 'CONTACT', 'email': 'marc.mcdowell@aah.org', 'phone': '708-684-6230'}], 'facility': 'Advocate Christ Medical Center Emergency Department (ACMC ED)', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}], 'centralContacts': [{'name': 'Marc McDowell, PharmD', 'role': 'CONTACT', 'email': 'marc.mcdowell@aah.org', 'phone': '(708) 684-1078'}], 'overallOfficials': [{'name': 'Travis Hase, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}