Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

Status:	Recruiting
Conditions:	Atrial Fibrillation
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	3/24/2019
Start Date:	April 2016
End Date:	April 2020
Contact:	David Amar, MD
Phone:	212-639-6798

A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery

This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone
alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting
>30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days
after major thoracic surgery.

Inclusion Criteria:

- Patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy,
lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four
following risk criteria:

- 1. Female & BNP ≥ 25pg/ml (no age limit)

- 2. Male gender <75 & BNP ≥ 25pg/ml

- 3. Male- age ≥75 (No BNP limit)

- 4. History of prior AF

- Patients in sinus rhythm.

- Patients with stable respiratory status (no respiratory distress).

- Patients capable of providing written, informed consent.

Exclusion Criteria:

- Patients scheduled for extrapleural pneumonectomy.

- Hemodynamically unstable patients (not in cardiogenic shock or having an acute MI).

- Patients with 2nd or 3rd degree atrioventricular (AV) block.

- Patients with hypersensitivity to amiodarone or NAC.

- Patients already taking class Ic or III antiarrhythmic drugs.

- Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels).

- Renal insufficiency (creatinine ≥2.0 mg/dl).

- Known pregnancy.

We found this trial at

sites

Memorial Sloan Kettering Cancer Center

1275 York Ave
New York, New York 10021

(212) 639-2000