Oral Bisoprolol Vs IV Diltiazem in Atrial Fibrillation or Flutter With Rapid Ventricular Rate.
Key facts
- Where
- Muscat, OmanSee the site
- Phase
- Phase 3
Where in Oman
- Sultan Qaboos University HospitalMuscat, OmanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oman Medical Speciality Board
- Trial code
- NCT06276127
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Oral Bisoprolol Versus Intravenous Diltiazem in the Management of Atrial Fibrillation or Flutter With Rapid Ventricular Rate in the Emergency Department: A Randomized Controlled Trial
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.
Inclusion: ≥ 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.
Exclusion: Acute myocardial infarction; Pre-excitation syndromes; Allergy to either bisoprolol or diltiazem; Severe hepatic and renal failure; A history of cocaine or methamphetamine use within 24 hours before arrival; 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); Known congenital and acquired valvular defects; Ventricular rate > 220beats/min; Pregnancy / breastfeeding; Known Asthmatic.