Actively Recruiting

Phase Not Applicable
Age: 60Years - 95Years
All Genders
NCT05062239

Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins

Led by Lars Peter Riber · Updated on 2025-04-23

100

Participants Needed

1

Research Sites

252 weeks

Total Duration

On this page

Sponsors

L

Lars Peter Riber

Lead Sponsor

O

Odense Patient Data Explorative Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Post-Operative Atrial Fibrillation After Surgical Aortic Valve Replacement and the Influence of Statins

Who Can Participate

Age: 60Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective solitary SAVR with bioprosthesis
  • Patients in sinus rhythm and not taking anti-arrhythmic medication other than beta-blockers at surgery
  • Treatment with HMG-CoA reductase inhibitors for at least 7 days in the past 3 months
  • Age over 60 years
  • Willingness to provide informed consent for randomization
Not Eligible

You will not qualify if you...

  • Prior history of atrial fibrillation
  • Prior history of cardiac surgery
  • Hepatic dysfunction with alanin-aminotransferase more than twice the upper limit
  • Creatinine level greater than 200 mol/L

AI-Screening

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Trial Site Locations

Total: 1 location

1

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

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Research Team

L

Lytfi Krasniqi, MD

CONTACT

L

Lars Riber, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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