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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Patients undergoing elective solitary SAVR with bioprosthesis
Patients in sinus rhythm and not taking any anti-arrhythmic medication other than beta-blockers at the time of surgery
No prior use of HMG-CoA reductase inhibitors in the last 3 months and at least 7 days before surgery
Age over 60 years
Willingness and provision of informed consent to be randomized
You will not qualify if you...
Prior history of atrial fibrillation
Prior history of cardiac surgery
Known adverse reaction to HMG-CoA reductase inhibitors
Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit)
Creatinine level above 200 bcmol/L
Known intolerance to statins or history of muscle toxicity with statins
Known intolerance to any excipients in Lipistad
Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) approximately 7 to 14 days prior to surgery
Treatment
Duration - From 7 to 14 days prior to surgery until 30 days postoperative
Participants take study medication (Atorvastatin or placebo) daily starting from 7 to 14 days before surgery until 30 days after surgery. They undergo surgical aortic valve replacement and continuous monitoring during hospital stay.
Hospital stay including continuous ECG monitoring up to post-operative day 5 and transthoracic echocardiography on post-operative day 3-5 plus a phone call on the 30th postoperative day
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Gender Differences in Predictors and Long-Term Mortality of New-Onset Postoperative Atrial Fibrillation Following Isolated Aortic Valve Replacement Surgery.
Mariana Fragão-Marques, Jennifer Mancio, João Oliveira...
Atorvastatin and the influence on postoperative atrial fibrillation after surgical aortic valve replacement (STARC) in adults at Odense University Hospital, Denmark: study protocol for a randomised controlled trial.
Lytfi Krasniqi, Axel Brandes, Poul Erik Mortensen...
2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC.
Gerhard Hindricks, Tatjana Potpara, Nikolaos Dagres...