Statin Pause Around Heart Valve Surgery and Irregular Heartbeat Afterward
Tests stopping statins before and after aortic valve replacement surgery.
Plain-language title generated from the registry record
Registry title: Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins
Key facts
- Where
- Odense, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 95 years old?
Source: NCT05062239, who can take part
Where in Denmark
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lars Peter Riber
- Trial code
- NCT05062239
- Record updated
- 23 April 2025
- Original description
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.Read full original descriptionShow less
Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins - Randomized Controlled Trial
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 investigate the risk of POAF, infection or other complications after SAVR in continuous versus preoperative discontinuous treatment with statins.
The study is a single centre randomized controlled trial with continuance treatment with statin vs. discontinuance (7 to 14 days prior surgery until the 30th post-operative day included), on patients undergoing elective solitary SAVR with bioprosthesis with prior usage of statins the last 3 months and of at least 7 days.
This randomized studies will address 2 separate hypotheses in patients undergoing open heart operation with solitary aortic valve replacement with a bioprosthetic valve that
1. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (<30 days) risk of POAF. 2. Discontinuation of HMG-CoA reductase inhibitors 7 to 14 days preoperative until 30 days postoperative of AVR in patients with prior use of HMG-CoA reductase inhibitors is not associated with increased early (<30 days) and intermediate (<1 year) risk of mortality, MI, stroke and rehospitalisation.
Inclusion: 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 HMG-CoA reductase inhibitors in the past 3 months and of at least 7 days; Age >60 years; Willingness and provision of informed consent to be randomized.
Exclusion: Prior history of atrial fibrillation; Prior history of cardiac surgery; Creatinine >200 µmol/L; Hepatic dysfunction (Alanin-aminotransferase more than twice the upper limit).