PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer

NCT ID: NCT01281787

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-10-31

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.

Conditions

Lung Cancer; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Losartan

angiotensin II-receptor blocker

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

no treatment

no preventive treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Metoprolol

beta-adrenergic antagonist

Group Type: ACTIVE_COMPARATOR

Metoprolol

Intervention Type: DRUG

Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Interventions

Metoprolol

Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Intervention Type: DRUG

Losartan

Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Intervention Type: DRUG

Other Intervention Names

SELOKEN, LOPRESOR; LORTAAN, NEOLOTAN, LOSAPREX

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniela Cardinale, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, Milan, Italy

Countries

Italy

Other Identifiers

2007-003856-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IEO S365/407

Identifier Type: -

Identifier Source: org_study_id