NCT05062239 Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins
| NCT ID | NCT05062239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lars Peter Riber |
| Condition | Postoperative Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-04-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05062239 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 95 Years, studying Postoperative Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05062239 currently recruiting?
Yes, NCT05062239 is actively recruiting participants. Contact the research team at Lytfi.krasniqi@rsyd.dk for enrollment information.
Where is the NCT05062239 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT05062239 clinical trial?
NCT05062239 is sponsored by Lars Peter Riber. The trial plans to enroll 100 participants.
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