Statin Therapy With Atorvastatin in Surgical Aortic Valve Replacement

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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 3 separate 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.

2. 7 to 14 days preoperative and until 30 days postoperative treatment with Atorvastatin 80 mg daily reduce early (<30 days) and intermediate (<1 year) mortality, MI, stroke and rehospitalisation in statin-naïve patients.

3. Atorvastatin 80 mg daily reduces the myocardial injury and inflammatory response and improves cardiac and renal function in statin-naïve patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Odense University Hospital
• Collaborators: GCP-unit at Odense University Hospital; Odense Patient Data Explorative Network
• Treatments: Atorvastatin

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