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

Primary Purpose

Lung Cancer, Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Metoprolol
Losartan
Sponsored by
European Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring FAP= post-surgery atrial fibrillation, ACEI= angiotensin converting enzyme-inhibitors, ARBs= angiotensin II receptor blockers, NT-proBNP= brain natriuretic peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European Institute of Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Losartan

no treatment

Metoprolol

Arm Description

angiotensin II-receptor blocker

no preventive treatment

beta-adrenergic antagonist

Outcomes

Primary Outcome Measures

Incidence of postoperative atrial fibrillation

Secondary Outcome Measures

Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay

Full Information

First Posted
December 21, 2010
Last Updated
June 17, 2014
Sponsor
European Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT01281787
Brief Title
PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
Acronym
PRESAGE
Official Title
Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute of Oncology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Active Comparator
Arm Description
angiotensin II-receptor blocker
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
no preventive treatment
Arm Title
Metoprolol
Arm Type
Active Comparator
Arm Description
beta-adrenergic antagonist
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
SELOKEN, LOPRESOR
Intervention Description
Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
LORTAAN, NEOLOTAN, LOSAPREX
Intervention Description
Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
Primary Outcome Measure Information:
Title
Incidence of postoperative atrial fibrillation
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Cardinale, MD
Organizational Affiliation
European Institute of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy

12. IPD Sharing Statement

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

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