protocolSection identificationModule nctId: NCT06276127, orgStudyIdInfo id: MERC301123, briefTitle: Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate., acronym: BisoAF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Oman Medical Speciality Board, class: OTHER_GOV, descriptionModule briefSummary: INTRODUCTION: The study focuses on comparing the effectiveness of oral Bisoprolol, a beta-1 adrenergic receptor blocker, against intravenous Diltiazem, a calcium channel blocker, in treating rapid atrial fibrillation or flutter with rapid ventricular response in an emergency setting. This research aims to fill the gap in empirical evidence regarding the use of oral Bisoprolol for these conditions, potentially offering a convenient, evidence-based alternative for patient management in emergency departments where established protocols are lacking.METHOD: This study is a randomized controlled trial targeting patients who present to the emergency room with symptomatic atrial fibrillation or flutter and rapid ventricular response requiring intervention. Participants will be split into two groups and undergo continuous monitoring of vital signs and regular electrocardiograms to ensure safety and document any adverse effects. The primary focus is on patient safety while evaluating the efficacy of the treatments.AIM: Evaluate the efficacy and safety of oral bisoprolol in treating atrial fibrillation or atrial flutter with rapid ventricular response in an emergency department setting.PRIMARY OJECTIVES: The primary efficacy outcome will be evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes. The primary safety outcome measures are HR \< 60 bpm and SBP \< 95 mm Hg.SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes., conditionsModule conditions: Atrial Fibrillation With Rapid Ventricular Response, conditions: Atrial Flutter With Rapid Ventricular Response, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: * Study Design: Double-blind, randomized controlled trial.* Participants: Patients with atrial fibrillation/flutter and rapid ventricular rate.* Treatment Arms: Oral Bisoprolol vs. Intravenous Diltiazem.* Randomization: Subjects randomly assigned to either treatment group.* Primary Endpoint: Reduction of heart rate to a target level within a specific timeframe.* Secondary Outcomes: Adverse effects, hospital admission rates, additional rate control needs.* Objective: Compare effectiveness and safety of oral Bisoprolol to intravenous Diltiazem.* Monitoring: Continuous observation of vital signs and electrocardiograms for safety., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: While the treating physician, nurse, and the patient will not be blinded to the treatment, the investigator collecting data and the statistician analysing it will remain blinded to treatment allocations. This ensures unbiased data collection and analysis., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Oral Bisoprolol, interventions name: Intravenous Diltiazem, outcomesModule primaryOutcomes measure: Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction, primaryOutcomes measure: Safety Outcome Evaluated by the Presence of serious adverse event, secondaryOutcomes measure: The use of Rescue medication, secondaryOutcomes measure: Proportion of patients who required hospitalization, secondaryOutcomes measure: ED revisit, secondaryOutcomes measure: Number of Participants Experiencing Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sultan Qaboos University Hospital, city: Muscat, state: Al-khod, zip: 38, country: Oman, contacts name: Fatin k Al omairi, MD, role: CONTACT, phone: 71308058, phoneExt: +968, email: r2220@resident.omsb.org, contacts name: Awatif Al-Alalawi, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Usama Alkhalasi, MD, role: SUB_INVESTIGATOR, contacts name: Mohamed Al Rawahi, MD, role: SUB_INVESTIGATOR, contacts name: Adil Al Riyami, MD, role: SUB_INVESTIGATOR, contacts name: Said Al Hadhrami, MD, role: SUB_INVESTIGATOR, contacts name: Hatim Al Lawati, MD, role: SUB_INVESTIGATOR, geoPoint lat: 23.58413, lon: 58.40778, hasResults: False