Actively Recruiting

Phase 3
Age: 18Years - 85Years
All Genders
NCT05169866

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

Led by Beijing Anzhen Hospital · Updated on 2024-06-03

274

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and younger than 85 years
  • New-onset atrial fibrillation occurring in the ICU after cardiac surgery
  • Atrial fibrillation lasting more than 1 minute and up to 48 hours
  • Hemodynamically stable with systolic blood pressure over 90 mmHg and mean arterial pressure over 60 mmHg without increasing vasoactive drugs
  • Received pre-treatment including electrolyte correction, volume optimization, oxygenation improvement, temperature control, pain relief, and minimal use of inotropes and vasopressors
  • Clinician considers antiarrhythmic drugs are needed
  • Informed consent obtained from patient or family
Not Eligible

You will not qualify if you...

  • History of heart transplantation, left heart assist device, or extracorporeal membrane oxygenation treatment
  • Previous atrial fibrillation, atrial flutter, or paroxysmal supraventricular tachycardia
  • Prior radiofrequency ablation
  • Rheumatic heart disease
  • Complex congenital heart disease with more than two defects
  • Cardiac tumors
  • Transcatheter valve interventions such as TAVI, TMVI, or TTVI
  • Contraindications to amiodarone or nifekalant including PR interval over 240ms, advanced atrioventricular block, QT interval over 440ms, familial long QT syndrome, untreated thyroid disease, elevated liver enzymes, liver cirrhosis, or interstitial lung disease
  • Heart rate below 50 beats/min or QRS duration over 140ms without a pacemaker
  • Use of amiodarone or nifekalant within 6 weeks before surgery
  • Pregnant or breastfeeding women
  • Uncorrected low potassium or magnesium levels
  • Chronic kidney failure or on continuous renal replacement therapy
  • Return to operating room during ICU stay or ICU readmission from cardiac surgery ward
  • Other factors deemed unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Anzhen Hospital

Beijing, China

Actively Recruiting

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Research Team

X

Xiaotong Hou, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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