Using Atorvastatin to prevent postoperative atrial fibrillation in heart surgery patients
Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement - a Randomized Controlled Trial
NA · Odense University Hospital · NCT05076019
This study is testing if taking Atorvastatin before and after heart surgery can help prevent a common heart rhythm problem called atrial fibrillation in patients who are having their aortic valve replaced.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 266 (estimated) |
| Ages | 60 Years to 95 Years |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 1 site (Odense) |
| Trial ID | NCT05076019 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Atorvastatin, a statin medication, on preventing postoperative atrial fibrillation (POAF) in patients undergoing surgical aortic valve replacement. Participants will be randomly assigned to receive either Atorvastatin 80mg or a placebo starting 7 to 14 days before surgery and continuing until 30 days after the procedure. The study aims to determine if this prophylactic treatment can reduce the incidence of POAF and other complications associated with cardiac surgery. Continuous ECG monitoring will be employed to detect any occurrences of atrial fibrillation during hospitalization.
Who should consider this trial
Good fit: Ideal candidates are patients over 60 years old undergoing elective solitary surgical aortic valve replacement who are in sinus rhythm and not on anti-arrhythmic medications.
Not a fit: Patients with a prior history of atrial fibrillation or those with significant hepatic or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of postoperative atrial fibrillation and improve recovery outcomes for heart surgery patients.
How similar studies have performed: While the use of statins in this context is promising, the specific application of Atorvastatin for preventing POAF in surgical aortic valve replacement is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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. No prior use of HMG-CoA reductase inhibitors the last 3 months and at least 7 days prior to the time of surgery 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. Known adverse reaction to HMG-CoA reductase inhibitors 4. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit) 5. Creatinine \>200 µmol/L 6. Known intolerance to statins or history of muscle toxicity with statins 7. Known intolerance to any of the excipients in Lipistad 8. Treatment with anti-viral medicine (glecaprevir/pibrentasvir) for hepatitis
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (RECRUITING)
Study contacts
- Study coordinator: Lytfi Krasniqi, MD
- Email: Lytfi.krasniqi@rsyd.dk
- Phone: 42772085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Atrial Fibrillation