RecruitingNot ApplicableNCT05076019

Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial


Sponsor

Odense University Hospital

Enrollment

266 participants

Start Date

Feb 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 examine the ability of a clinically durable Atorvastatin prophylactic regime to prevent the development of POAF and other postoperative complications in these patients. Patients will be randomized to Atorvastatin 80mg or placebo 7 to 14 days preoperative until 30 days postoperative - a total of 37 to 44 days of treatment. The medication will be double blinded. The randomized studie will address the following hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that 1\) 7 to 14 days preoperative and until 30 days postoperative treatment with Atorvastatin 80 mg daily reduces the incidence of POAF in statin-naïve patients.


Eligibility

Min Age: 60 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether taking a statin medication (atorvastatin) around the time of aortic valve replacement surgery can help prevent atrial fibrillation (an irregular heart rhythm) after the operation. **You may be eligible if...** - You are over 60 years old - You are scheduled for elective surgical aortic valve replacement with a biological valve - You are in normal heart rhythm (sinus rhythm) and not taking anti-arrhythmic drugs (beta-blockers are okay) - You have not taken a statin in the past 3 months **You may NOT be eligible if...** - You have a history of atrial fibrillation - You have had previous heart surgery - You have liver problems or kidney issues (creatinine > 200 µmol/L) - You have had a bad reaction to statins or muscle problems from statins - You are taking certain antiviral medications (for hepatitis) 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.

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Interventions

DRUGAtorvastatin 80mg

Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative

DRUGPlacebo

Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative


Locations(1)

Odense University Hospital

Odense, Denmark

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NCT05076019


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