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

NCT00300495 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 2005P000376
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Lung Cancer

Keywords

Atrial fibrillation; Lung cancer; Pulmonary resection; Post-operative complications

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-operative Atrial Fibrillation

  Number of patients with post-operative atrial fibrillation

  30 days

Secondary Outcomes (1)

• Length of Post-operative Hospital Stay

  1 week on average

Study Arms (2)

1 - Amiodarone

EXPERIMENTAL

Perioperative amiodarone

Drug: Amiodarone

2 - Control

ACTIVE COMPARATOR

Control arm, standard care with no perioperative amiodarone

Other: Control arm, standard care

Interventions

Amiodarone DRUG

Perioperative orally administered

Also known as: Cordarone, Pacerone

1 - Amiodarone

Control arm, standard care OTHER

Control

2 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resectable lung nodule or mass

You may not qualify if:

• Allergy to amiodarone
• Currently taking amiodarone
• Documented atrial fibrillation within past 12 months
• Known pulmonary fibrosis
• Known hepatic dysfunction
• Thyroid disease
• nd or 3rd degree heart block
• Severe SA node disease
• Bradycardia-induced syncope
• Pregnancy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Lung Neoplasms

Interventions

Amiodarone; Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Min Kim
• Organization: Houston Methodist Hospital

mpkim@houstonmethodist.org

7134415177

Study Officials

• Malcolm M DeCamp, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 9, 2006
• Study Start: February 1, 2006
• Primary Completion: October 13, 2009
• Study Completion: October 13, 2009
• Last Updated: April 28, 2017
• Results First Posted: April 28, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)