PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer

Study Overview
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Brief Summary
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The aim of this study is to assess whether prophylactic treatment with metoprolol or losartan is able to reduce the incidence of atrial fibrillation (AF) in patients undergoing thoracic surgery for lung cancer, showing elevated plasma levels in NT probrain natriuretic peptide (NT-proBNP), measured in the perioperative period.

Detailed Description
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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.

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

Conditions
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Lung Cancer, Atrial Fibrillation

Intervention / Treatment
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* Drug: Metoprolol
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Losartan<br>angiotensin II-receptor blocker | Drug: Losartan<br>* Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay<br>* Other names: LORTAAN, NEOLOTAN, LOSAPREX;|
| No Intervention: no treatment<br>no preventive treatment | |
| Active Comparator: Metoprolol<br>beta-adrenergic antagonist | Drug: Metoprolol<br>* Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay<br>* Other names: SELOKEN, LOPRESOR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative atrial fibrillation |  | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay |  | up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide