PREvention of Atrial Fibrillation in patientS Undergoing thorAcic surGEry for Lung Cancer
PRESAGE
Prevention of Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer
2 other identifiers
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 lung-cancer
Started Apr 2008
Typical duration for phase_3 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
January 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJune 18, 2014
June 1, 2014
5.2 years
December 21, 2010
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative atrial fibrillation
up to 10 days
Secondary Outcomes (1)
Evaluation of NT-proBNP in the days following the start of treatment and post surgery duration of hospital stay
up to 10 days
Study Arms (3)
Losartan
ACTIVE COMPARATORangiotensin II-receptor blocker
no treatment
NO INTERVENTIONno preventive treatment
Metoprolol
ACTIVE COMPARATORbeta-adrenergic antagonist
Interventions
Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
Eligibility Criteria
You may qualify if:
- Patients of both sexes with age ≥ 18 years
- Thoracic surgery for lung cancer
- Evidence of elevated perioperative NT-proBNP
- Written informed consent
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, Milan, 20141, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Cardinale, MD
European Institute of Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2010
First Posted
January 24, 2011
Study Start
April 1, 2008
Primary Completion
June 1, 2013
Study Completion
October 1, 2013
Last Updated
June 18, 2014
Record last verified: 2014-06