Clinical trial NCT05730413: Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
Official title: Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Bypass Grafting
Postoperative Atrial Fibrillation
Coronary Artery Disease
Keywords: Bisoprolol
Dosage regimens
heart rate
blood pressure
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this interventional clinical trial is compare between two different dose regimens of bisoprolol (beta-blocker) in CABG patients in terms of efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* Adult patients: 18 to 65 years old
* Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery

Exclusion Criteria:

* History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III
* History of Sick sinus syndrome, sinoatrial heart block
* History of valve replacement
* Permanent Pacemaker
* LVEF less than 30%
* Unstable Heart failure
* Cardiogenic shock
* Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment
* Severe chronic obstructive airway disease
* Severe asthma unless was on previously tolerated bisoprolol dose
* Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose
* Pregnant/Lactation
* Previous recent stroke
* Creatinine clearance less than 30 ml/min
* End stage liver disease (liver cirrhosis)
* Drug dependance history
* Untreated phaeochromocytoma
* Vasospastic angina
* Thyrotoxicosis
* History of advanced staged of peripheral vascular disease
* Hypersensitivity
* Patients on any other beta-blocker other than bisoprolol
* Patients on bisoprolol higher than 5 mg/day.

Primary outcomes:
measure: Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
timeFrame: 5 days
Secondary outcomes:
measure: Onset time of Atrial Fibrillation
timeFrame: 5 days
measure: Recurrence of Atrial Fibrillation
timeFrame: 5 days
measure: Mean reduction in heart rate
timeFrame: Hospital stay ( up to 10 days)
measure: Mean resting heart rate
timeFrame: Hospital stay ( up to 10 days)
measure: Mean systolic and diastolic blood pressure
timeFrame: Hospital stay (up to 10 days)
measure: Length of ICU stay
timeFrame: ICU stay (up to 5 days)
measure: Length of Hospital stay
timeFrame: Hospital stay (up to 10 days)
measure: Medication safety
timeFrame: Hospital stay (up to 10 days)
measure: Bisoprolol concentration
timeFrame: time before next dose post average 24 hours
measure: Use of inotropes/vasopressors
timeFrame: ICU stay (up to 5 days)
measure: ICU mortality
timeFrame: ICU stay (up to 5 days)
measure: Hospital Mortality
timeFrame: Hospital Stay (up to 10 days)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El-Demerdash Cardiac Academy Hospital
Study officials:
affiliation: Cairo University
name: Reem Ihab, Bsc
role: PRINCIPAL_INVESTIGATOR
References: