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Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial


Phase 4
18 Years
N/A
Not Enrolling
Both
Atrial Fibrillation

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Trial Information

Amiodarone Prophylaxis for Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer: A Controlled, Randomized, Double Blinded Trial


Inclusion Criteria:



- Resection of the lung due to confirmed diagnosis of cancer pulmones.

- Elective operation (scheduled operation for at least one day)

- Ready to be randomized

- Patient must be at least 18 at time of operation

Exclusion Criteria:

- Former operation of the lung

- Former heart surgery

- Bradycardia below 40 beats/ min

- Hypotension with systolic blood pressure below 80 mmHg

- AV-blockage of any degree or sick sinus node

- QTc interval above 440 ms for men or above 460 ms for women

- Paroxysmal, persistent or permanent atrial fibrillation or flutter

- Former atrial fibrillation or flutter for more than a month.

- Pregnant or positive pregnancy test

- Breastfeeding

- ALAT of more than twice the normal over limit

- Treatment with monoamineoxidase inhibitors (MAOI)

- Allergy to one or more components in amiodarone

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Free of atrial fibrillation

Outcome Time Frame:

31082009

Safety Issue:

Yes

Principal Investigator

Lars R Zebis, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital Skejby

Authority:

Denmark: Danish Medicines Agency

Study ID:

2612-3681

NCT ID:

NCT00724581

Start Date:

August 2008

Completion Date:

December 2009

Related Keywords:

  • Atrial Fibrillation
  • Atrial fibrillation, amiodarone
  • Atrial Fibrillation
  • Lung Neoplasms

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