Clinical trial NCT01281787: PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
Official title: Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Atrial Fibrillation
Keywords: FAP= post-surgery atrial fibrillation
ACEI= angiotensin converting enzyme-inhibitors
ARBs= angiotensin II receptor blockers
NT-proBNP= brain natriuretic peptide
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* Heart rate \<65 b / m
* History of bronchial asthma, severe bronchopneumopathy, evidence of bronchospasm

Primary outcomes:
measure: Incidence of postoperative atrial fibrillation
timeFrame: up to 10 days
Secondary outcomes:
measure: Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Daniela Cardinale, MD
role: PRINCIPAL_INVESTIGATOR
References: