Official Title: “Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection”

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.

Study Type: Interventional

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

Study Primary Completion Date: January 2011

Intervention(s) in this Clinical Trial

• Drug: Amiodarone
  • Perioperative orally administered
• Drug: Amiodarone
  • Perioperative oral amiodarone
• Other: Control arm, standard care
  • Control

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Perioperative amiodarone
• Active Comparator: 2
  • Control arm, standard care with no perioperative amiodarone

Primary Measures

• Incidence of post-operative atrial fibrillation
  • Time Frame: 30 days
    Safety Issue?: No

Secondary Measures

• Hospital charges
  • Time Frame: 1 week on average
    Safety Issue?: No
• Length of post-operative hospital stay
  • Time Frame: 1 week on average
    Safety Issue?: No
• Incidence of other post-operative complications
  • Time Frame: 30 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Beth Israel Deaconess Medical Center

Overall Clinical Trial Officials and Contacts

Malcolm M DeCamp, MD Principal Investigator Beth Israel Deaconess Medical Center  

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300495

Study ID Number: 2005P000376

ClinicalTrials.gov Identifier: NCT00300495

Health Authority: United States: Institutional Review Board