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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 95
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Lytfi Krasniqi, MD
Lytfi.krasniqi@rsyd.dk
+4542772085
Backup
Lars Riber, MD
lars.riber@rsyd.dk
21450354
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Continuance
Continuance prior statin therapy.
Experimental: Discontinuance
Discontinuance prior statin therapy. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
Sponsors
Leads: Lars Peter Riber
Collaborators: Odense Patient Data Explorative Network, GCP-unit at Odense University Hospital

This content was sourced from clinicaltrials.gov