Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00300495

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Lung Cancer	Drug: Amiodarone Other: Control arm, standard care	Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Cancer Lung Cancer Surgery

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Study of Preoperative Amiodarone for Prevention of Atrial Fibrillation After Lung Resection

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Incidence of post-operative atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hospital charges [ Time Frame: 1 week on average ] [ Designated as safety issue: No ]
Length of post-operative hospital stay [ Time Frame: 1 week on average ] [ Designated as safety issue: No ]
Incidence of other post-operative complications [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	February 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Perioperative amiodarone	Drug: Amiodarone Perioperative orally administered Drug: Amiodarone Perioperative oral amiodarone
2: Active Comparator Control arm, standard care with no perioperative amiodarone	Other: Control arm, standard care Control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300495

Contacts

Contact: Malcolm M DeCamp, MD

617-632-8386

mdecamp@bidmc.harvard.edu

Locations

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

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

Malcolm M DeCamp, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	BIDMC ( Malcolm DeCamp Jr., MD )
Study ID Numbers:	2005P000376
Study First Received:	March 8, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00300495 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Atrial fibrillation
Lung cancer
Pulmonary resection
Post-operative complications

Study placed in the following topic categories:

Thoracic Neoplasms
Vasodilator Agents
Heart Diseases
Respiratory Tract Diseases
Postoperative Complications
Lung Neoplasms

Lung Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Atrial Fibrillation
Amiodarone
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Amiodarone
Neoplasms

Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009