Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection

Condition(s) targeted: Atrial Fibrillation; Lung Cancer

Intervention: Amiodarone (Drug); Amiodarone (Drug); Control arm, standard care (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Malcolm M DeCamp, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Overall contact:
Malcolm M DeCamp, MD, Phone: 617-632-8386, Email: mdecamp@bidmc.harvard.edu

Atrial fibrillation is a very common complication of pulmonary resection. Patients who develop atrial fibrillation require additional treatment and are more likely to stay in the hospital for longer period of time increasing the costs associated with the operation. We propose a randomized controlled trial to see if oral amiodarone given for one week before surgery can prevent atrial fibrillation after pulmonary resection. We plan to evaluate the incidence of atrial fibrillation in patients who received preoperative amiodarone and compare them to the incidence of atrial fibrillation in patients who did not received preoperative amiodarone.

Official title: Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Incidence of post-operative atrial fibrillation

Secondary outcome:

Hospital charges

Length of post-operative hospital stay

Incidence of other post-operative complications

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Resectable lung nodule or mass

Exclusion Criteria:

- Allergy to amiodarone

- Currently taking amiodarone

- Documented atrial fibrillation within past 12 months

- Known pulmonary fibrosis

- Known hepatic dysfunction

- Thyroid disease

- 2nd or 3rd degree heart block

- Severe SA node disease

- Bradycardia-induced syncope

- Pregnancy

Malcolm M DeCamp, MD, Phone: 617-632-8386, Email: mdecamp@bidmc.harvard.edu

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Malcolm M DeCamp, MD, Phone: 617-632-8386, Email: mdecamp@bidmc.harvard.edu
Malcolm M DeCamp, MD, Principal Investigator

Starting date: February 2006
Ending date: March 2011
Last updated: May 5, 2008