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

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Description

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.

Targeted Conditions

Study Overview

Start Date
October 1, 2023
Completion Date
January 31, 2025
Enrollment
3280
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Alaa Rahal
Doha, DA 3050, Qatar

Hamad medical corporation
Doha, DA 3050, Qatar

Eligibility

Study Population
The study will include 2 groups: Group 1: Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week prior to surgery regardless of DM status (SGLT2 inhibitor users) Group 2: Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery (SGLT2 inhibitor non-users)
Minimum Age (years)
18
Maximum Age (years)
70
Eligibility Criteria
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 Contact Info

Study Contact Name
Alaa Rahhal, Msc
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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).
NCTid (if applicable)
NCT06251453