Post-Operative Atrial Fibrillation after Surgical Aortic Valve Replacementand the influence of HMG-CoA reductase inhibitors

Phase 1

Recruiting

• Conditions: Patients undergoing surgical aortic valve replacement.; MedDRA version: 20.0Level: LLTClassification code: 10003660Term: Atrial fibrillation and flutter Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-511601-34-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Trial 1: Patients undergoing elective solitary SAVR with bioprosthesis; Patients who are in sinus rhythm and not taking any anti-arrhythmic medication; other than beta-adrenergic blocking agents; at the time of surgery; No prior use of statin the last 3 months and at least 7 days prior to the time of surgery Age >60 years; Willingness and provision of informed consent to be randomized. Trial 2: Patients undergoing elective solitary SAVR with bioprosthesis; Patients who are in sinus rhythm and not taking any anti-arrhythmic medication other than beta-adrenergic blocking agents, at the time of surgery; In treatment with statin in the past 3 months and of at least 7 days Age >60 years; Willingness and provision of informed consent to be randomized.

Exclusion Criteria

Prior history of atrial fibrillation; Prior history of cardiac surgery; Known adverse reaction to statin; Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit); Creatinine >200 µmol/L; Known intolerance to statins or history of muscle toxicity with statins.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified