Do statins prevent atrial rhythm disturbances after cardiac surgery?

• Research type

  Research Study

• Full title

  Prevention of atrial oxidative stress and electrical remodelling in patients undergoing cardiac surgery: randomised placebo-controlled trial of perioperative high-dose atorvastatin

• IRAS ID

  23031

• Contact name

  Barbara Casadei

• Sponsor organisation

  Oxford University Hospitals NHS Foundation Trust

• Eudract number

  2009-013228-21

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Atrial fibrillation (AF) is the most common irregularity of the heart rhythm in humans that involves the upper chambers of the heart (ie, the atria). Following open cardiac surgery, 35ð-50% of patients develops AF within the first 7 postoperative days; this may lead to clinical deterioration, prolong hospital & intensive care stay. Emerging evidence suggests that systemic inflammation and atrial oxidative stress (the process in which highly reactive molecules such as reactive oxygen species (ROS) impair particular cellular functions) associated with cardiac surgery may play an important role in the development of AF and that a class of drugs called statins may be protective. In this study we will investigate whether perioperative administration of high dose Atorvastatin would prevent atrial oxidative stress and electrical changes in the atrial myocardium that promote AF after cardiac surgery. We aim to recruit 80 patients who have a regular heart rhythm and are awaiting conventional (on pump) coronary artery bypass surgery (with or without associated valve surgery). Participants will be randomly allocated to the study drug (Atorvastatin 80 mg daily) or a placebo (a dummy pill) for up to a total of 12 days (up to 7 days before surgery and for 5 days after). After surgery, patients will undergo studies of atrial electrical activity and continuous heart rhythm monitoring. Samples of the right atrial appendage (part of the right atrium) which are routinely removed (and discarded) as part of the surgical procedure will be evaluated for inflammation/oxidative stress.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/35

• Date of REC Opinion

  24 Jun 2010

• REC opinion

  Further Information Favourable Opinion