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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003856-12 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Active Comparator | angiotensin II-receptor blocker |
|
| no treatment | No Intervention | no preventive treatment | |
| Metoprolol | Active Comparator | beta-adrenergic antagonist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative atrial fibrillation | up to 10 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Additional exclusion criteria for therapy with beta-blocker:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Cardinale, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Losartan | Drug | Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay |
|
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |