[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07632157":3,"trial-entities:NCT07632157":138,"trial-summary:NCT07632157":143},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":54,"secondary_outcomes":59,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":110,"locations":113,"central_contacts":123,"overall_officials":132,"references":136,"see_also_links":137},"NCT07632157","IRB00146620","MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation","MAGNEsium With meToprolol for Rate Control In Atrial Fibrillation (MAGNETIC-AF)","NOT_YET_RECRUITING","2028-12","2026-06","2026-06-29","2026-10","Wake Forest University Health Sciences","OTHER",false,"The purpose of this research study is to find out if the use of magnesium in addition to Metoprolol, a rate controlling medication that you would be offered in the Emergency Department today unrelated to this study, will help reduce your high heart rate (rapid ventricular response).","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. 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 atrial fibrillation or atrial flutter with rapid ventricular response. This study will use flat-dose intravenous metoprolol for rate control to minimize confounders. Additionally, this study will not require a resulted magnesium level prior to treatment in order to avoid delays in patient care.",[19],"Atrial Flutter With Rapid Ventricular Response",[21,22,23],"AFF RVR","intravenous magnesium","atrial flutter","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},196,"ESTIMATED",[32,40,47],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Magnesium Sulfate 2g","Magnesium Sulfate 2g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)",[37],"Experimental Arm One, Magnesium Sulfate 2g followed by metoprolol 5 mg",[39],"Magnesium Sulfate 2 gram\u002F50ml 0.9% NaCl",{"type":33,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Magnesium Sulfate 4g","Magnesium Sulfate 4g for the treatment of atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR)",[44],"Experimental Arm Two, Magnesium Sulfate 4g followed by metoprolol",[46],"Magnesium Sulfate 4 gram\u002F50ml 0.9% NaCl",{"type":33,"name":48,"description":49,"armGroupLabels":50,"otherNames":52},"Saline (0.9% NaCl)","The control group will receive a bolus of normal saline of the same volume and infused over 15 minutes.",[51],"Control Arm, normal saline followed by metoprolol",[53],"Control (50ml 0.9% NaCl)",[55],{"measure":56,"description":57,"timeFrame":58},"Ventricular rate control","Assessing ventricular rate control within the first 2 hours of intravenous magnesium administration as defined as a ventricular rate of \\\u003C 120 beats per minute.","Within the first 2 hours of intravenous magnesium administration",[60,64,68,71,75,79,83,86],{"measure":61,"description":62,"timeFrame":63},"Mean change in heart rate","Mean change in heart rate after the administration of magnesium sulfate","up to 24 hours after magnesium infusion",{"measure":65,"description":66,"timeFrame":67},"Incidence of hypotension","Systolic blood pressure \\\u003C 90 or MAP \\\u003C 65","At 1 and 2 hours after magnesium administration",{"measure":69,"description":70,"timeFrame":67},"Incidence of bradycardia","Heart rate \\\u003C 60 beats per minute",{"measure":72,"description":73,"timeFrame":74},"Mean time to achieve goal heart rate","Mean time to achieve goal heart rate at 2 hours","at 2 hours",{"measure":76,"description":77,"timeFrame":78},"Rate of conversion","Rate of conversion to normal sinus rhythm","2 hours after administration of magnesium",{"measure":80,"description":81,"timeFrame":82},"Clinical need for rescue medication administration","Dose of rescue medications given (magnesium and metoprolol)","2 hours from metoprolol administration",{"measure":84,"description":85,"timeFrame":63},"Mean change in heart rhythm","Mean change in heart rhythm after the administration of magnesium sulfate",{"measure":80,"description":87,"timeFrame":82},"Route of administration (IV or PO) for rescue medications (magnesium and metoprolol), if administered.","ALL","18 Years",null,{"inclusion":92,"exclusion":98,"raw_text":109},[93,94,95,96,97],"Age \\> 18 years or older","Able to provide informed consent","Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute","Metoprolol as rate control agent","English speaking",[99,100,101,102,103,104,105,106,107,108],"Hemodynamically unstable patients (SBP \\\u003C90, MAP \\\u003C65)","Impaired consciousness","Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and\u002For additional imaging","Patient in AFF RVR that is highly suspected to be a compensatory mechanism for an alternative clinical diagnosis","Rhythms other than atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response","Acute myocardial infarction","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","Inclusion Criteria:\n\n* Age \\> 18 years or older\n* Able to provide informed consent\n* Primary diagnosis atrial fibrillation or atrial flutter with rapid ventricular response (AFF RVR) greater than or equal to 120 beats per minute\n* Metoprolol as rate control agent\n* English speaking\n\nExclusion Criteria:\n\n* Hemodynamically unstable patients (SBP \\\u003C90, MAP \\\u003C65)\n* Impaired consciousness\n* Acute heart failure exacerbation based on clinical diagnosis, physician exam, bedside echo, and\u002For 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 atrial fibrillation, such as sick sinus syndrome or wide-complex ventricular response\n* Acute myocardial infarction\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",[111,112],"ADULT","OLDER_ADULT",[114],{"facility":115,"city":116,"state":117,"zip":118,"country":119,"geoPoint":120},"Advocate Christ Medical Center Emergency Department (ACMC ED)","Oak Lawn","Illinois","60453","United States",{"lat":121,"lon":122},41.71087,-87.75811,[124,129],{"name":125,"role":126,"phone":127,"email":128},"Marc McDowell, PharmD","CONTACT","(708) 684-1078","marc.mcdowell@aah.org",{"name":130,"role":126,"email":131},"Thomas Szwajnos","Thomas.Szwajnos@aah.org",[133],{"name":125,"affiliation":134,"role":135},"Advocate Christ Medical Center Emergency Department","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":139,"biomarkers":142},[140,141],"Atrial Fibrillation","Atrial Flutter",[],{"nct_id":4,"found":15,"summary":90,"prompt_version":90}]