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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251453
• Other study ID #: MRC-01-23-470
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: Hamad Medical Corporation
• Contact: Alaa Rahhal, Msc
• Phone: 55712353
• Email: ARahhal1[@]hamad.qa
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3280
• Est. completion date: January 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• SGLT2 inhibitor
Dapagliflozin Empagliflzoin

Locations

Country	Name	City	State
Qatar	Alaa Rahal	Doha	DA
Qatar	Hamad medical corporation	Doha	DA

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative atrial fibrillation (POAF)	Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination	1 month
Secondary	Euglycemic diabetic ketoacidosis	Incidence of euglycemic diabetic ketoacidosis after surgery	1 month
Secondary	Urinary tract infection	Incidence of urinary tract infection after surgery	1 month