Atrial Fibrillation, Lung Cancer
Conditions
Keywords
FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide
Brief summary
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
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.
Interventions
DRUGMetoprolol
Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
DRUGLosartan
Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
Sponsors
European Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative atrial fibrillation | up to 10 days |
Secondary
| Measure | 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 |
Countries
Italy
Outcome results
None listed