RecruitingPhase 3NCT05169866

Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery

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


Sponsor

Beijing Anzhen Hospital

Enrollment

274 participants

Start Date

May 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two drugs — nifekalant and amiodarone — for treating new-onset atrial fibrillation (an irregular heartbeat) that occurs after cardiac surgery in the ICU. Both drugs are given intravenously to try to restore a normal heart rhythm. **You may be eligible if...** - You are 18–84 years old - You developed atrial fibrillation after cardiac surgery while in the ICU - Your atrial fibrillation has lasted more than 1 minute but less than 48 hours - Your blood pressure is stable and you do not need increasing doses of vasopressors - Your doctor has decided anti-arrhythmic medication is needed after addressing other potential causes **You may NOT be eligible if...** - You received a heart transplant, left ventricular assist device (LVAD), or ECMO - You have a history of atrial fibrillation, atrial flutter, or rapid supraventricular heartbeats before surgery - You have had radiofrequency ablation, rheumatic heart disease, or complex congenital heart disease - You have contraindications to amiodarone or nifekalant (e.g., heart block, prolonged QT interval, untreated thyroid disease, severe liver or lung disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNifekalant

Patients identified with new-onset atrial fibrillation with a sustained duration of greater than 1 minutes and less than 48 hours will be considered for the study. Patients randomized to nifekalant arm will receive a bolus of 0.3mg/kg IV in the first 5 minutes and a maintenance dose of 0.2-0.4mg/kg/h for 24 hours.

DRUGAmiodarone

Patients identified with new-onset atrial fibrillation with a sustained duration of greater than 1 minutes and less than 48 hours will be considered for the study. Patients randomized to amiodarone arm will receive a bolus of 150mg IV in the first 10 minutes and a maintenance dose of 0.5-1mg/min for 24 hours.


Locations(1)

Beijing Anzhen Hospital

Beijing, China

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NCT05169866


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