Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.

Summary

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.

Timeline

Start

2025-04

Primary completion

2027-04

Completion

2027-06

Publications

• Background clinical_evaluation_of_bisoprolol_in_the_treatment.31.
• Background The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II)-.
• Results Fromm C, Suau SJ, Cohen V, Likourezos A, Jellinek-Cohen S, Rose J, Marshall J. Diltiazem vs. Metoprolol in the Management of Atrial Fibrillation or Flutter with Rapid Ventricular Rate in the Emergency Department. J Emerg Med. 2015 Aug;49(2):175-82. doi: 10.1016/j.jemermed.2015.01.014. Epub 2015 Apr 22.
• Results January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
• Results Posen A, Bursua A, Petzel R. DOsing Strategy Effectiveness of Diltiazem in Atrial Fibrillation With Rapid Ventricular Response. Ann Emerg Med. 2023 Mar;81(3):288-296. doi: 10.1016/j.annemergmed.2022.08.462. Epub 2022 Nov 17.
• Results Saksena S, Slee A, Waldo AL, Freemantle N, Reynolds M, Rosenberg Y, Rathod S, Grant S, Thomas E, Wyse DG. Cardiovascular outcomes in the AFFIRM Trial (Atrial Fibrillation Follow-Up Investigation of Rhythm Management). An assessment of individual antiarrhythmic drug therapies compared with rate control with propensity score-matched analyses. J Am Coll Cardiol. 2011 Nov 1;58(19):1975-85. doi: 10.1016/j.jacc.2011.07.036.
• Results Groenveld HF, Crijns HJ, Tijssen JG, Alings M, Hillege HL, Tuininga YS, Van den Berg MP, Van Veldhuisen DJ, Van Gelder IC. Rate control in atrial fibrillation, insight into the RACE II study. Neth Heart J. 2013 Apr;21(4):199-204. doi: 10.1007/s12471-013-0391-1. No abstract available.
• Results Bakheit AH, Ali R, Alshahrani AD, El-Azab AS. Bisoprolol: A comprehensive profile. Profiles Drug Subst Excip Relat Methodol. 2021;46:51-89. doi: 10.1016/bs.podrm.2020.07.006. Epub 2020 Sep 8.
• Results Ishiguro H, Ikeda T, Abe A, Tsukada T, Mera H, Nakamura K, Yusu S, Yoshino H. Antiarrhythmic effect of bisoprolol, a highly selective beta1-blocker, in patients with paroxysmal atrial fibrillation. Int Heart J. 2008 May;49(3):281-93. doi: 10.1536/ihj.49.281.
• Results A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). CIBIS Investigators and Committees. Circulation. 1994 Oct;90(4):1765-73. doi: 10.1161/01.cir.90.4.1765.
• Results Demircan C, Cikriklar HI, Engindeniz Z, Cebicci H, Atar N, Guler V, Unlu EO, Ozdemir B. Comparison of the effectiveness of intravenous diltiazem and metoprolol in the management of rapid ventricular rate in atrial fibrillation. Emerg Med J. 2005 Jun;22(6):411-4. doi: 10.1136/emj.2003.012047.
• Results Hasbrouck M, Nguyen TT. Acute management of atrial fibrillation in congestive heart failure with reduced ejection fraction in the emergency department. Am J Emerg Med. 2022 Aug;58:39-42. doi: 10.1016/j.ajem.2022.03.058. Epub 2022 Apr 6.
• Results Nicholson J, Czosnowski Q, Flack T, Pang PS, Billups K. Hemodynamic comparison of intravenous push diltiazem versus metoprolol for atrial fibrillation rate control. Am J Emerg Med. 2020 Sep;38(9):1879-1883. doi: 10.1016/j.ajem.2020.06.034. Epub 2020 Jun 21.

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