Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Incidence of postoperative atrial fibrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with age ≥ 18 years
- •Thoracic surgery for lung cancer
- •Evidence of elevated perioperative NT-proBNP
- •Written informed consent
排除标准
- •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
研究组 & 干预措施
Losartan
angiotensin II-receptor blocker
干预措施: Losartan (Drug)
Metoprolol
beta-adrenergic antagonist
干预措施: Metoprolol (Drug)
结局指标
主要结局
Incidence of postoperative atrial fibrillation
时间窗: up to 10 days
次要结局
- Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay(up to 10 days)