Comparing Nifekalant and Amiodarone for Atrial Fibrillation After Heart Surgery

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

This study is testing whether a new heart medication called nifekalant is safer and more effective than amiodarone for treating atrial fibrillation in patients who have just had heart surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05169866 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness and safety of nifekalant, a novel antiarrhythmic agent, against amiodarone in treating new-onset atrial fibrillation (AF) in patients following cardiac surgery. Atrial fibrillation is a common complication that can lead to increased morbidity and prolonged hospital stays. The study will enroll patients who are hemodynamically stable and have experienced AF for more than one minute but less than 48 hours post-surgery. By evaluating the outcomes of both medications, the trial seeks to determine if nifekalant offers a safer and more effective alternative to amiodarone, which has several side effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 who have developed postoperative atrial fibrillation in the ICU after cardiac surgery.

Not a fit: Patients who have undergone heart transplantation, are on ECMO, or have a history of atrial fibrillation or certain heart conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a safer and more effective treatment option for patients experiencing atrial fibrillation after cardiac surgery.

How similar studies have performed: While nifekalant has shown efficacy in other forms of atrial fibrillation, its specific use in postoperative settings compared to amiodarone has not been previously reported, making this a novel approach.

Eligibility criteria

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

Where this trial is running

Beijing

• Beijing Anzhen Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Xiaotong Hou, MD, PhD — Beijing Anzhen Hospital
• Study coordinator: Xiaotong Hou, MD, PhD

Conditions New Onset Atrial Fibrillation; Complications; Cardiac, Postoperative; Nifekalant; Amiodarone; Cardiac Surgery; Postoperative Atrial Fibrillation