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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06251453
Enrollment
3280
Registered
2024-02-09
Start date
2023-10-01
Completion date
2025-01-31
Last updated
2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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).

Interventions

DRUGSGLT2 inhibitor

Dapagliflozin Empagliflzoin

Sponsors

Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of post-operative atrial fibrillation (POAF)1 monthConfirmed AF after surgery, regardless of frequency, duration, or intervention used for termination

Secondary

MeasureTime frameDescription
Euglycemic diabetic ketoacidosis1 monthIncidence of euglycemic diabetic ketoacidosis after surgery
Urinary tract infection1 monthIncidence of urinary tract infection after surgery

Countries

Qatar

Contacts

Primary ContactAlaa Rahhal, Msc
ARahhal1@hamad.qa55712353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026