PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Lung Cancer Atrial Fibrillation |
| Intervention | Drug: Metoprolol Drug: Losartan |
| Phase | Phase 3 |
| Sponsor | European Institute of Oncology |
| Responsible Party | European Institute of Oncology |
| ClinicalTrials.gov Identifier | NCT01281787 |
| First Received | December 21, 2010 |
| Last Updated | September 4, 2012 |
| Last verified | September 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 21, 2010 |
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| Last Updated Date | September 4, 2012 |
| Start Date | April 2008 |
| Estimated Primary Completion Date | December 2015 |
| Current Primary Outcome Measures | Incidence of postoperative atrial fibrillation [Time Frame: up to 10 days] [Designated as safety issue: No] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer |
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| Official Title | Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer |
| Brief 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Metoprolol Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay Other Names: SELOKEN, LOPRESORDrug: Losartan Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay Other Names: LORTAAN, NEOLOTAN, LOSAPREX |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
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| Estimated Enrollment | 300 |
| Estimated Completion Date | December 2015 |
| Estimated Primary Completion Date | December 2012 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Daniela Cardinale, MD daniela.cardinale@ieo.it |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01281787 |
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| Other Study ID Numbers | IEO S365/407 |
| Has Data Monitoring Committee | No |
| Information Provided By | European Institute of Oncology |
| Study Sponsor | European Institute of Oncology |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Daniela Cardinale, MD European Institute of Oncology |
| Verification Date | September 2012 |
Locations[ + expand ][ + ]
| European Institute of Oncology | Milan, Italy, 20141 Contact: daniela cardinale, MD | 39.02.57489539 | daniela.cardinale@ieo.itPrincipal Investigator: Daniela Cardinale, MD Recruiting |
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