TerminatedPhase 3NCT00300495
Official study title

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

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedAmiodarone and Control arm, standard care

The study team can explain what participation involves.

Who it may be forAtrial Fibrillation · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 28, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Beth Israel Deaconess Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Prevention
Study type
Interventional
Phase
Phase 3
Sponsor
Beth Israel Deaconess Medical Center
Interventions being studied
Drug: Amiodarone; Other: Control arm, standard care
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Resectable lung nodule or mass

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Beth Israel Deaconess Medical CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 28, 2017. Always confirm current availability with the study team.

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