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

June 17, 2014 updated by: European Institute of Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

320

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • SELOKEN, LOPRESOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative atrial fibrillation
Time Frame: up to 10 days
up to 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

January 21, 2011

First Posted (ESTIMATE)

January 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO S365/407
  • 2007-003856-12 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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