A Randomized Active-Controlled Study Comparing Efficacy and Safety of Nifekalant to Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery

2021-15

Postoperative atrial fibrillation is a major complication of cardiac surgery, which could lead to high morbidity and mortality, increase duration of hospital stay and increase the cost of treatment. New-onset atrial fibrillation after cardiac surgery is considered as a multifactorial phenomenon. Amiodarone, the most commonly used drug for cardioversion, is limited in atrial fibrillation after cardiac surgery due to side effects such as hypotension, bradycardia, and extracardiac side effects. Nifekalant is a novel class III antiarrhythmic agent with short onset time. It is a pure potassium channel blocker, which generally does not cause hypotension and bradycardia. There have been several trials that proven efficacy of nifekalant in converting persistent atrial fibrillation. For atrial fibrillation after cardiac surgery, the effectiveness and safety of nifekalant compared to amiodarone have not yet been reported. The investigators plan to perform a clinical trial comparing nifekalant to amiodarone in new-onset atrial fibrillation after cardiac surgery patients with a primary outcome of cardioversion at 4 hours. Secondary outcomes will follow cardioversion at 90 minutes and 24 hours, maintenance time of sinus rhythm within 24 hours, average time to conversion to sinus rhythm, rate of hypotension, length of ICU stay, length of hospital stay and hospital mortality.

2022-05-29

2025-05-01

2025-06-01

Recruiting

Early phase I

274

Inclusion Criteria: 1. Age ≥18 years old, \<85 years old, no gender limit; 2. Postoperative atrial fibrillation in the ICU after cardiac surgery; 3. The duration of atrial fibrillation\> 1 minute, and ≤ 48 hours; 4. Hemodynamically stable (no need to increase vasoactive drugs and SBP\>90/MAP\>60mmHg); 5. After pre-treatment (including: correcting electrolyte disturbances, optimizing volume status, improving oxygenation, controlling body temperature, analgesia and minimizing the use of inotropes and vasopressors), the clinician believes that antiarrhythmic drugs are needed. 6. Obtained the informed consent from the patients or their family members. Exclusion Criteria: 1. Heart transplantation, left heart assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) treatment; 2. History of atrial fibrillation/atrial flutter and a history of paroxysmal supraventricular tachycardia; 3. Radiofrequency ablation; 4. Rheumatic heart disease; 5. Complex congenital heart disease (with more than two coexisting congenital heart defects); 6. Cardiac tumors; 7. Transcatheter aortic valve implantation (TAVI), transcatheter mitral valve intervention (TMVI), and transcatheter tricuspid valve intervention (TTVI); 8. Contraindications to amiodarone/nifekalant (PR interval\>240ms; 2nd or 3rd degree atrioventricular block (AVB); QT\>440ms; familial long QT syndrome; Untreated thyroid disease; AST or ALT\>2 times the upper limit; liver cirrhosis; interstitial lung disease); 9. Heart rate (HR) \<50 beats/min and/or QRS\>140ms without a pacemaker; 10. Received amiodarone or nifekalant within 6 weeks before the operation; 11. Pregnant and lactating female patients; 12. Uncorrected hypokalemia (serum potassium \<3.5mmol/L) or hypomagnesemia (whole blood/serum magnesium below the lower limit); 13. Chronic renal failure and/or continuous renal replacement therapy (CRRT); 14. Return to OR during ICU stay or readmission to ICU from Cardiac Surgery ward. 15. Other factors not suitable for participating in this study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 274, 'type': 'ESTIMATED'}}

2024-06-03