RecruitingNot ApplicableNCT05062239

Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins

Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins - Randomized Controlled Trial


Sponsor

Lars Peter Riber

Enrollment

100 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Statins have rapid and significant actions that have potentially important (but not yet proven) implications for postoperative atrial fibrillation and cardiac protection in patients undergoing cardiac surgery. The focus of this study is, therefore, on patients having surgical aortic valve replacement (with aortotomy) and the development of postoperative atrial fibrillation (POAF). Our aims are: to investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins. The study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days. This randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that 1. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) risk of POAF. 2. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (\<30 days) and intermediate (\<1 year) risk of mortality, MI, stroke and rehospitalisation.


Eligibility

Min Age: 60 YearsMax Age: 95 Years

Inclusion Criteria5

  • Patients undergoing elective solitary SAVR with bioprosthesis
  • Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery
  • In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days
  • Age \>60 years
  • Willingness and provision of informed consent to be randomized

Exclusion Criteria4

  • Prior history of atrial fibrillation
  • Prior history of cardiac surgery
  • Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
  • Creatinine \>200 µmol/L

Interventions

DRUGDiscontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative

Discontinuance of prior statin therapy

DRUGNo-intervention.

Continuance of prior statin therapy


Locations(1)

Odense University Hospital

Odense, Denmark

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NCT05062239


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