PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer (PRESAGE)
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.
|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|
- Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]
- 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 ]
|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)|
Active Comparator: Losartan
angiotensin II-receptor blocker
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
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
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.
|Contact: Daniela Cardinale, MDfirstname.lastname@example.org|
|Contact: Carlo M Cipolla, MDemail@example.com|
|European Institute of Oncology||Recruiting|
|Milan, Italy, 20141|
|Contact: daniela cardinale, MD 39.02.57489539 firstname.lastname@example.org|
|Contact: carlo M cipolla, MD 39.02.57489539 email@example.com|
|Principal Investigator: Daniela Cardinale, MD|
|Principal Investigator:||Daniela Cardinale, MD||European Institute of Oncology|