Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251453
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-09-27
Brief Title:
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SGLT2 inhibitors are oral anti-diabetic medications that were found to improve cardiorenal outcomes in patients with type 2 diabetes mellitus DM chronic heart failure with reduced and preserved ejection fraction and chronic kidney disease Recent evidence suggested that the use of SGLT2 inhibitors resulted in a significant reduction in atrial fibrillation AF over a mean follow-up duration of 26 years Given the possible AF protective benefit with SGLT2 inhibitors use
Detailed Description:
we aim to conduct a retrospective cohort study to evaluate the impact of SGLT2 inhibitors use on post-operative AF POAF among patients undergoing cardiothoracic surgery including coronary artery bypass grafting CABG valve replacement and valve repair over a 6-year period from 1062017 to 1072023 The follow-up period will be the post-operative hospital stay or 30-days whichever is shorter and the data will be obtained from the electronic medical records The study outcomes will include effectiveness outcomes of incidence of POAF regardless of frequency duration or intervention used for termination incidence of paroxysmal POAF incidence of paroxysmal POAF requiring pharmacological cardioversion incidence of hemodynamically unstable POAF requiring electrical cardioversion incidence of persistent POAF sustained beyond 7 days incidence of POAF requiring anticoagulation ischemic stroke and safety outcomes of euglycemic diabetic ketoacidosis and urinary tract infections UTI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None