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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer; Atrial Fibrillation	Drug: Metoprolol; Drug: Losartan	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	320 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Study Start Date :	April 2008
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Losartan; angiotensin II-receptor blocker	Drug: Losartan; Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay; Other Name: LORTAAN, NEOLOTAN, LOSAPREX
No Intervention: no treatment; no preventive treatment
Active Comparator: Metoprolol; beta-adrenergic antagonist	Drug: Metoprolol; Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay; Other Name: SELOKEN, LOPRESOR

Outcome Measures

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Primary Outcome Measures :

1. Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ]

Secondary Outcome Measures :

1. Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay [ Time Frame: up to 10 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
European Institute of Oncology
Milan, Italy, 20141

Sponsors and Collaborators

European Institute of Oncology

Investigators

Principal Investigator:	Daniela Cardinale, MD	European Institute of Oncology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	European Institute of Oncology
ClinicalTrials.gov Identifier:	NCT01281787 History of Changes
Other Study ID Numbers:	IEO S365/407; 2007-003856-12 ( EudraCT Number )
First Posted:	January 24, 2011
Last Update Posted:	June 18, 2014
Last Verified:	June 2014

Keywords provided by European Institute of Oncology:

FAP= post-surgery atrial fibrillation; ACEI= angiotensin converting enzyme-inhibitors; ARBs= angiotensin II receptor blockers; NT-proBNP= brain natriuretic peptide

Additional relevant MeSH terms:

Lung Neoplasms; Atrial Fibrillation; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Losartan; Metoprolol; Angiotensin Receptor Antagonists

Angiotensin II; Angiotensin-Converting Enzyme Inhibitors; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Molecular Mechanisms of Pharmacological Action; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents