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

This study is currently recruiting participants.

Verified September 2012 by European Institute of Oncology

Sponsor:

Information provided by (Responsible Party):

European Institute of Oncology

ClinicalTrials.gov Identifier:

NCT01281787

First received: December 21, 2010

Last updated: September 4, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2010

Last Updated Date

September 4, 2012

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01281787 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Lung Cancer
Atrial Fibrillation

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: Losartan
angiotensin II-receptor blocker

Intervention: Drug: Losartan
No Intervention: no treatment
no preventive treatment
Active Comparator: Metoprolol
beta-adrenergic antagonist

Intervention: Drug: Metoprolol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Daniela Cardinale, MD		daniela.cardinale@ieo.it
Contact: Carlo M Cipolla, MD		carlo.cipolla@ieo.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01281787

Other Study ID Numbers ^ICMJE

IEO S365/407, 2007-003856-12

Has Data Monitoring Committee

Responsible Party

European Institute of Oncology

Study Sponsor ^ICMJE

European Institute of Oncology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Daniela Cardinale, MD

European Institute of Oncology

Information Provided By

European Institute of Oncology

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top