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The prevention effect of Sotalol for post-operative atrial fibrillation after coronary artery bypass grafting: a randomized contrlled trial

The prevention effect of Sotalol for post-operative atrial fibrillation after coronary artery bypass grafting: a randomized contrlled trial - Sotalol for POAF after CABG

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088934
Enrollment
Unknown
Registered
2024-08-29
Start date
2024-08-29
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

A:Sotalol
B:Metoprolol

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients who are willing to participate in this study and can sign the informed consent form (=18 years old on the day of surgery). 2. Patients scheduled for elective isolated coronary artery bypass grafting surgery (without valve surgery). 3. Patients with sinus rhythm and no history of atrial fibrillation (including permanent atrial fibrillation, persistent atrial fibrillation, paroxysmal atrial fibrillation, and initial atrial fibrillation), and who do not need to use antiarrhythmic drugs (except beta-blockers) during surgery.

Exclusion criteria

Exclusion criteria: 1. Sinus bradycardia (heart rate 450 milliseconds, congenital or acquired long QT syndrome and history of torsade de pointes. 4. Incorrigible hypokalemia (<3.5 mmol/L), hypomagnesemia <0.75 mmol/L. 5. Acute myocardial infarction (occurring within two months), clinically uncontrolled heart failure (EF <40%), infective endocarditis, active pericarditis or myocarditis. 6. Bronchial asthma, severe obstructive pulmonary disease or other contraindications to beta-blocker therapy. 7. Creatinine clearance rate <40 ml/min. 8. Use of antiarrhythmic drug therapy (except beta-adrenergic receptor blockers). 8. History of drug allergy and serious adverse reactions to sotalol and metoprolol. 9. In any blood pressure measurement during preoperative hospitalization, systolic blood pressure <100 mmHg, or preoperative need for intravenous pumping of positive vasoactive drugs (such as dopamine, norepinephrine, epinephrine, etc.).

Design outcomes

Primary

MeasureTime frame
postoperative atrial fibrillation;

Secondary

MeasureTime frame
all-cause death;cardiovascular-related death;stroke;post-operative length of stay;post-operative length of ICU stay;in-hospital cost;

Countries

China

Contacts

Public ContactChenfei Rao

Fuwai Hospital, Chinese Academy of Medical Sciences

raochenfeifuwai@126.com+86 188 1048 8801

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026