Effects of Statins on Atrial Fibrillation After Aortic Valve Surgery
Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins - Randomized Controlled Trial
NA · Odense University Hospital · NCT05062239
This study tests whether taking statins before and after aortic valve surgery can help prevent heart rhythm problems in patients undergoing the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 60 Years to 95 Years |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 1 site (Odense) |
| Trial ID | NCT05062239 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of statin treatment on the occurrence of postoperative atrial fibrillation (POAF) in patients undergoing surgical aortic valve replacement (SAVR). It is a randomized controlled trial comparing continuous statin treatment with a discontinuation period of 7 to 14 days before surgery until 30 days post-operation. The trial aims to enroll 100 patients and will monitor for complications such as POAF and other cardiac issues during hospitalization. Continuous ECG monitoring will be utilized to detect AF, and patient eligibility will be assessed through a multidisciplinary team approach.
Who should consider this trial
Good fit: Ideal candidates are patients over 60 years old undergoing elective solitary surgical aortic valve replacement who have been on statin therapy for at least 7 days in the past 3 months.
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 study could lead to improved management strategies for preventing postoperative atrial fibrillation in cardiac surgery patients.
How similar studies have performed: While the approach of using statins in this context is being explored, similar studies have shown mixed results, indicating that this area is still under investigation.
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. In treatment with HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days 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. Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit) 4. Creatinine \>200 µmol/L
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: +4542772085
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