Impact of Sodium-glucose Cotransporter 2 Inhibitors on Post-operative Atrial Fibrillation in Cardiothoracic Surgery

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Drug: SGLT2 inhibitor

• Registration Number: NCT06251453
• Lead Sponsor: Hamad Medical Corporation

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 2.6 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 1/06/2017 to 1/07/2023). 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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study Start: 2023-10-01
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3280

Inclusion Criteria

• Adults > 18 years undergoing cardiothoracic surgery, including CABG, mechanical valve replacement, bioprosthetic valve replacement, or valve repair.
• Use of SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status.
• Resumption of SGLT2 inhibitor after stepping down from the intensive care unit.

Exclusion Criteria

• Known AF on anticoagulation.
• Chronic kidney disease with CrCl < 25 mL/min.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGLT2 inhibitors users	SGLT2 inhibitor	Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week before surgery, regardless of diabetes status

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative atrial fibrillation (POAF)	1 month	Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination

Secondary Outcome Measures

Name	Time	Method
Euglycemic diabetic ketoacidosis	1 month	Incidence of euglycemic diabetic ketoacidosis after surgery
Urinary tract infection	1 month	Incidence of urinary tract infection after surgery

Trial Locations

Locations (2)

Alaa Rahal; 🇶🇦 Doha, DA, Qatar

Hamad medical corporation; 🇶🇦 Doha, DA, Qatar