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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
  Purpose

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 Intervention Phase
Lung Cancer
Atrial Fibrillation
 Drug: Metoprolol
Drug: Losartan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by European Institute of Oncology:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01281787

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

Locations
Italy
European Institute of Oncology Recruiting
Milan, Italy, 20141
Contact: daniela cardinale, MD     39.02.57489539     daniela.cardinale@ieo.it    
Contact: carlo M cipolla, MD     39.02.57489539     carlo.cipolla@ieo.it    
Principal Investigator: Daniela Cardinale, MD            
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Daniela Cardinale, MD European Institute of Oncology
  More Information

No publications provided

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT01281787     History of Changes
Other Study ID Numbers: IEO S365/407, 2007-003856-12
Study First Received: December 21, 2010
Last Updated: September 4, 2012
Health Authority: Italy: The Italian Medicines Agency

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:
Atrial Fibrillation
Lung Neoplasms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Angiotensin II
Metoprolol
Natriuretic Peptide, Brain
 Losartan
Angiotensin-Converting Enzyme Inhibitors
Metoprolol succinate
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents

ClinicalTrials.gov processed this record on June 13, 2013