Comparing once versus twice daily bisoprolol for preventing atrial fibrillation after heart surgery
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
PHASE4 · Cairo University · NCT05730413
This study is testing whether taking bisoprolol once a day or twice a day can help prevent heart rhythm problems after heart surgery for people with coronary artery disease.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05730413 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of two different dosing regimens of bisoprolol, a beta-blocker, in patients undergoing coronary artery bypass graft (CABG) surgery. The study will involve adult patients diagnosed with coronary heart disease or myocardial infarction who are scheduled for CABG. Participants will be assigned to receive either a once-daily or twice-daily dosage of bisoprolol, and outcomes related to the prevention of postoperative atrial fibrillation will be assessed. The trial seeks to determine which regimen is more effective in managing heart rate and blood pressure post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with coronary heart disease or a history of myocardial infarction scheduled for CABG.
Not a fit: Patients with a history of significant arrhythmias, severe heart failure, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of atrial fibrillation in patients after heart surgery, enhancing recovery and reducing complications.
How similar studies have performed: While similar studies have explored beta-blocker regimens, this specific comparison of dosing frequency in CABG patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- El-Demerdash Cardiac Academy Hospital — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Reem Ihab, Bsc — Cairo University
- Study coordinator: Reem Ihab, Bsc
- Email: reem.ihab@pharma.cu.edu.eg
- Phone: +0201144481391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Bypass Grafting, Postoperative Atrial Fibrillation, Coronary Artery Disease, Bisoprolol, Dosage regimens, heart rate, blood pressure