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ID05076019

Preventing Postoperative Atrial Fibrillation with Atorvastatin in Patients Undergoing Surgical Aortic Valve Replacement

Led by Odense University Hospital · Updated on 2024-10-08

266

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of atorvastatin, a statin medication, on preventing postoperative atrial fibrillation POAF and other complications in patients undergoing elective surgical aortic valve replacement with a bioprosthetic valve. This trial focuses on patients who have no prior history of atrial fibrillation or flutter and are statin-nafve. The study aims to determine if a preoperative and postoperative atorvastatin regimen can reduce the incidence and duration of POAF. Participants will be randomly assigned to receive either atorvastatin 80 mg or a placebo once daily, starting 7 to 14 days before surgery and continuing until 30 days after surgery, totaling 37 to 44 days of treatment. The study medication is provided in tablet form and is double-blinded to ensure unbiased results. During the hospital stay, patients will be closely monitored, including continuous ECG and Holter monitoring, blood tests for cardiac enzymes and inflammation markers, and echocardiography. Participants will undergo detailed assessments before, during, and after surgery, including physical exams, blood sampling, and heart function imaging. Continuous ECG monitoring will detect atrial fibrillation during hospitalization and up to 30 days postoperatively. Follow-up includes phone calls to evaluate symptoms related to atrial fibrillation. Researchers will measure the occurrence and length of POAF, myocardial injury, stroke, kidney injury, and other complications. Safety and recovery will be tracked until hospital discharge and beyond, with monitoring of medications and interventions used during and after surgery.

CONDITIONS

Brief Title

Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

Research Team

L

Lytfi Krasniqi, MD

L

Lars Peter Riber, MD

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