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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01281787
First received: December 21, 2010
Last updated: June 17, 2014
Last verified: June 2014
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 ]
Enrollment: 320
Study Start Date: April 2008
Study Completion Date: October 2013
Primary Completion Date: June 2013 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281787

Locations
Italy
European Institute of Oncology
Milan, Italy, 20141
Sponsors and Collaborators
European Institute of Oncology
Investigators
Principal Investigator: Daniela Cardinale, MD European Institute of Oncology
  More Information

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: June 17, 2014
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:
Lung Neoplasms
Atrial Fibrillation
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Losartan
Metoprolol
Angiotensin Receptor Antagonists
 Angiotensin II
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 28, 2016