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Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

Phase 3
18 Years
Open (Enrolling)
Lung Cancer, Atrial Fibrillation

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Trial Information

Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

Postoperative atrial fibrillation is one of the most common complication after thoracic
surgery for lung cancer, with an incidence ranging from 8 to 20% after lobectomy and up to
42% after pneumonectomy.

In a recent study we demonstrated that a high perioperative plasma levels of NT-proBNP is
able to identify patients at risk for AF (incidence of 65%).

It has also been demonstrated that the renin-angiotensin system may play an important role
in the pathophysiology of atrial fibrillation and that angiotensin converting enzyme
inhibitors (ACEI) and angiotensin II receptor blockers (ARBs) are able to prevent atrial
fibrillation in patients with heart failure, after myocardial infarction, in hypertensive
patients and after electrical cardioversion.

Inclusion Criteria:

- Patients of both sexes with age ≥ 18 years

- Thoracic surgery for lung cancer

- Evidence of elevated perioperative NT-proBNP

- Written informed consent

Exclusion Criteria:

- Hypersensitivity and / or intolerance to metoprolol or losartan

- History of heart failure

- Left ventricular ejection fraction <50% measured by echocardiographic techniques
(Simpson rule)

- Permanent atrial fibrillation

- Antiarrhythmic therapy

- Current therapy with beta-blockers, angiotensin II receptor blockers and
angiotensin-converting enzyme inhibitors

- Systolic blood pressure <95 mmHg

- Pregnant and lactating women

Additional exclusion criteria for therapy with beta-blocker:

- History of sick sinus syndrome, evidence of AV-block grade II or greater

- Heart rate <65 b / m

- History of bronchial asthma, severe bronchopneumopathy, evidence of bronchospasm

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of postoperative atrial fibrillation

Outcome Time Frame:

up to 10 days

Safety Issue:


Principal Investigator

Daniela Cardinale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

European Institute of Oncology


Italy: The Italian Medicines Agency

Study ID:

IEO S365/407



Start Date:

April 2008

Completion Date:

December 2015

Related Keywords:

  • Lung Cancer
  • Atrial Fibrillation
  • FAP= post-surgery atrial fibrillation
  • ACEI= angiotensin converting enzyme-inhibitors
  • ARBs= angiotensin II receptor blockers
  • NT-proBNP= brain natriuretic peptide
  • Atrial Fibrillation
  • Lung Neoplasms