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Trial record 7 of 7 for:    "Lung Disease" | "Metoprolol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01281787
Recruitment Status : Completed
First Posted : January 24, 2011
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Tracking Information
First Submitted Date  ICMJE December 21, 2010
First Posted Date  ICMJE January 24, 2011
Last Update Posted Date June 18, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2011)
Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ]
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
 (submitted: January 21, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2014)
320
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2011)
300
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date June 2013   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01281787
Other Study ID Numbers  ICMJE IEO S365/407
2007-003856-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account European Institute of Oncology
Verification Date June 2014

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