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

Last updated: February 8, 2024
Sponsor: Hamad Medical Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

SGLT2 inhibitor

Clinical Study ID

NCT06251453
MRC-01-23-470
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 3280
Treatment Group(s): 1
Primary Treatment: SGLT2 inhibitor
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
January 31, 2025

Study 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).

Connect with a study center

  • Alaa Rahal

    Doha, DA 3050
    Qatar

    Active - Recruiting

  • Hamad medical corporation

    Doha, DA 3050
    Qatar

    Active - Recruiting

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