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Completed

NCT Number: NCT01281787

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

European Institute of Oncology

Milan, 20141, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metoprolol

Drug

Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Other names: SELOKEN, LOPRESOR

Losartan

Drug

Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay

Other names: LORTAAN, NEOLOTAN, LOSAPREX

Primary outcomes

  1. Incidence of postoperative atrial fibrillation

    Time frame: 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

    Time frame: up to 10 days

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Acronym: PRESAGE

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2011
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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