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

Recruiting now · Not applicable

Conditions studied: Postoperative Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05062239

Run by

Lars Peter Riber

People needed

100

Starts

2022-04-01

Expected to finish

2027-02-01

Last updated by the study team

2025-04-23

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Odense University Hospital — Odense, Denmark (enrolling)

Full record on ClinicalTrials.gov

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