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

Plain Language Summary

Simplified for easier understanding

This study examines whether statin medications (cholesterol-lowering drugs) reduce the risk of atrial fibrillation (an irregular heartbeat) that commonly develops after open-heart surgery to replace the aortic valve (SAVR). Patients who are already on statins are randomized to continue or stop them around the time of surgery. **You may be eligible if...** - You are over 60 and scheduled for an elective surgical aortic valve replacement (SAVR) with a tissue valve - You are currently taking statins (cholesterol-lowering drugs) and have been for at least 7 days - You are in normal heart rhythm (sinus rhythm) and not on other heart rhythm medications **You may NOT be eligible if...** - You have a history of atrial fibrillation - You have previously had heart surgery - You have significant liver or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05062239


Related Trials