Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Overview
- Phase
- Phase 3
- Intervention
- Losartan
- Conditions
- Lung Cancer
- Sponsor
- European Institute of Oncology
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative atrial fibrillation
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Losartan
angiotensin II-receptor blocker
Intervention: Losartan
Metoprolol
beta-adrenergic antagonist
Intervention: Metoprolol
Outcomes
Primary Outcomes
Incidence of postoperative atrial fibrillation
Time Frame: up to 10 days
Secondary Outcomes
- Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay(up to 10 days)