PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer (PRESAGE)
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ClinicalTrials.gov Identifier: NCT01281787 |
Recruitment Status
:
Completed
First Posted
: January 24, 2011
Last Update Posted
: June 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer Atrial Fibrillation | Drug: Metoprolol Drug: Losartan | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | October 2013 |

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 Name: LORTAAN, NEOLOTAN, LOSAPREX
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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
|
- Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281787
Italy | |
European Institute of Oncology | |
Milan, Italy, 20141 |
Principal Investigator: | Daniela Cardinale, MD | European Institute of Oncology |
Responsible Party: | European Institute of Oncology |
ClinicalTrials.gov Identifier: | NCT01281787 History of Changes |
Other Study ID Numbers: |
IEO S365/407 2007-003856-12 ( EudraCT Number ) |
First Posted: | January 24, 2011 Key Record Dates |
Last Update Posted: | June 18, 2014 |
Last Verified: | June 2014 |
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 |