PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer - Full Text View

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.

Condition	Intervention	Phase
Lung Cancer Atrial Fibrillation	Drug: Metoprolol Drug: Losartan	Phase 3


Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation Lung Cancer

Drug Information available for: Metoprolol Metoprolol tartrate Metoprolol succinate Losartan Metoprolol fumarate Losartan potassium

U.S. FDA Resources

Further study details as provided by European Institute of Oncology:

Primary Outcome Measures:

Incidence of postoperative atrial fibrillation [ Time Frame: up to 10 days ] [ Designated as safety issue: No ]

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 ]


Enrollment:	320
Study Start Date:	April 2008
Study Completion Date:	October 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Losartan angiotensin II-receptor blocker	Drug: Losartan 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 beta-adrenergic antagonist	Drug: 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

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281787

Locations


Italy
European Institute of Oncology
Milan, Italy, 20141

Sponsors and Collaborators

European Institute of Oncology

Investigators


Principal Investigator:	Daniela Cardinale, MD	European Institute of Oncology

More Information

No publications provided


Responsible Party:	European Institute of Oncology
ClinicalTrials.gov Identifier:	NCT01281787 History of Changes
Other Study ID Numbers:	IEO S365/407, 2007-003856-12
Study First Received:	December 21, 2010
Last Updated:	June 17, 2014
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by European Institute of Oncology:


FAP= post-surgery atrial fibrillation ACEI= angiotensin converting enzyme-inhibitors ARBs= angiotensin II receptor blockers NT-proBNP= brain natriuretic peptide

Additional relevant MeSH terms:


Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Metoprolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Anti-Arrhythmia Agents	Antihypertensive Agents Autonomic Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sympatholytics Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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