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

RecruitingNAAges 60 Years - 95 YearsAllLars Peter Riber
NCT05062239 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 wi

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients undergoing elective solitary SAVR with bioprosthesis 2. Patients who are in sinus rhythm and not taking any anti-arrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery 3. In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days 4. Age \>60 years 5. Willingness and provision of informed consent to be randomized Exclusion Criteria: 1. Prior history of atrial fibrillation 2. Prior history of cardiac surgery 3. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit) 4. Creatinine \>200 µmol/L
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What it tests

  • Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative
  • No-intervention.
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Where

1 site
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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