PREvention of atrial fibrillation in patientS undergoing thorAcic surGEry for lung cance - PRESAGE
- Conditions
- lung cancer patients undergoing thoracic surgeryMedDRA version: 9.1Level: LLTClassification code 10026532Term: Malignant neoplasm of thorax
- Registration Number
- EUCTR2007-003856-12-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Male or female patients older than 18 years. Thoracic surgery for lung cancer High peri-operative values of NT-proBNP. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Intollerance to metoprolol and/or losartan History of heart failure Ejection fraction <50% Permanent FA Treatment with antiarythmics, beta blockers, angiotensin II blockers, ACE inhibitors Sistolic blood pressure < 95 mmHg
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate the possibility to prevent FA after thoracic surgery through beta-blocker administration vs an angiotensin II inhibitor (losartan)in high risk patients with high peri-operative values of NT-proBNP;Secondary Objective: to evaluate if prevention correlates with a reduction of NT-proBNP levels.;Primary end point(s): incidence of FA episodes after surgery
- Secondary Outcome Measures
Name Time Method