PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
Information source: European Institute of Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer; Atrial Fibrillation
Intervention: Metoprolol (Drug); Losartan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: European Institute of Oncology Official(s) and/or principal investigator(s):
Daniela Cardinale, MD, Principal Investigator, Affiliation: European Institute of Oncology
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.
Clinical Details
Official title: Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of postoperative atrial fibrillation
Secondary outcome: Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
European Institute of Oncology, Milan 20141, Italy
Additional Information
Starting date: April 2008
Last updated: June 17, 2014
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