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

NCT06276127 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MERC301123
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation With Rapid Ventricular Response; Atrial Flutter With Rapid Ventricular Response

Keywords

Bisoprolol; AF; Diltiazem; Atrial flutter

Outcome Measures

Primary Outcomes (2)

• Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction

  The primary efficacy outcome evaluated by achieving a HR\<110 beats per minute or a decrease ≥20% of baseline HR at 60 minutes

  at 60 minutes

• Safety Outcome Evaluated by the Presence of serious adverse event

  The primary safety outcome measures were HR \< 60 bpm and SBP \< 95 mm Hg

  at 60 minutes

Secondary Outcomes (4)

• The use of Rescue medication

  60 minutes

• Proportion of patients who required hospitalization

  90 minutes

• ED revisit

  First 48 hour from discharge

• Number of Participants Experiencing Treatment-Related Adverse Events

  First 48 hour after receive intervention

Study Arms (2)

Oral Bisoprolol

EXPERIMENTAL

A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg)

Drug: Oral Bisoprolol

Intravenous Diltiazem

OTHER

single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg)

Drug: Intravenous Diltiazem

Interventions

Oral Bisoprolol DRUG

Participants in this group will receive a single oral dose of Bisoprolol, set at a dosage of 5 mg, with a maximum dose limit of 5 mg.

Also known as: Bisoprolol hemifumarate

Oral Bisoprolol

Intravenous Diltiazem DRUG

Participants in this group will be administered a single intravenous dose of diltiazem at a dosage of 0.25 mg/kg, with a maximum dose capped at 30 mg.

Also known as: Diltiazem nondihydropyridine calcium channel blocker

Intravenous Diltiazem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old.
• Atrial fibrillation (RVR) or Atrial flutter on electrocardiogram.
• Heart rate \>120 beats/min
• Stable patient with stable vital signs (Defined as having a SBP \>110 mmHg, oxygen saturation \> 94% on room air or with a simple face mask, a respiratory rate within normal limits, being conscious and oriented, and not having any concurrent life-threatening conditions such as myocardial infarction (MI) or Class IV heart failure).
• Mentally competent patient who can understand and sign the consent form.

You may not qualify if:

• Acute myocardial infarction.
• Known congenital and acquired valvular defects.
• Pre-excitation syndromes.
• Ventricular rate \> 220beats/min.
• Administration of AV nodal blocking agents within the previous 24 h (beta blockers, non-dihydropyridine calcium channel blockers, digoxin and amiodarone or receiving regular maintains oral dose).
• Allergy to either bisoprolol or diltiazem.
• Severe hepatic and renal failure.
• Pregnancy / breastfeeding.
• A history of cocaine or methamphetamine use within 24 hours before arrival.
• Known Asthmatic.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Al-khod, 38, Oman

Location

Related Publications (13)

• 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.

  PMID: 25913166 BACKGROUND

• 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.

  PMID: 24685669 BACKGROUND

• 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.

  PMID: 36402632 BACKGROUND

• 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.

  PMID: 22032709 BACKGROUND

• 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.

  PMID: 23468405 BACKGROUND

• 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.

  PMID: 33461700 BACKGROUND

• clinical_evaluation_of_bisoprolol_in_the_treatment.31.

  BACKGROUND

• 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.

  PMID: 18612186 BACKGROUND

• 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.

  PMID: 7923660 BACKGROUND

• The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II)-.

  BACKGROUND

• 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.

  PMID: 15911947 BACKGROUND

• 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.

  PMID: 35623182 BACKGROUND

• 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.

  PMID: 32745920 BACKGROUND

Related Links

• Lawrence Rosenthal MPFFP of MDS of CP and ED of EFPD of CDU of MMMC. Atrial Flutter.
• Diltiazem

MeSH Terms

Conditions

Atrial Flutter

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Usama Al Khalasi, MD

  The Medical City for Military & Security Services, Oman

  STUDY CHAIR

Central Study Contacts

Fatin ALOmairi, MD

CONTACT

71308058; r2220@resident.omsb.org

Fatin AlOmairi, MD

CONTACT

71308058; fatin.khalfan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: While the treating physician, nurse, and the patient will not be blinded to the treatment, the statistician analyzing it will remain blinded to treatment allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Emergency Medicine, OMSB

Model Details: Study Design: Open-label, 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.

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data from our study will be available soon after its completion and will remain accessible for a period of 3 years.
• Access Criteria: Open Access Policy: The document is accessible to anyone who requests it, promoting widespread dissemination.

Locations

OM (1)