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

Lung Cancer Clinical Trial

— PRESAGE  

Official title:

Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281787
• Other study ID #: IEO S365/407
• Secondary ID: 2007-003856-12
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2010
• Last updated: June 17, 2014
• Start date: April 2008
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Metoprolol
Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
• Losartan
Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative atrial fibrillation		up to 10 days	No
Secondary	Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay		up to 10 days	No