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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: SGLT2 inhibitor

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 Type: Observational
• Enrollment (Estimated): 3280

Contacts and Locations

• Study Contact: Name: Alaa Rahhal, Msc; Phone Number: 55712353; Email: ARahhal1@hamad.qa

Study Locations

• Qatar
  • DA
    • Doha, DA, Qatar, 3050
      • Recruiting
      • Hamad Medical Corporation
      • Contact: Alaa Rahal, Msc Pharma; Phone Number: 66346543; Email: ARahhal1@hamad.qa
    • Doha, DA, Qatar, 3050
      • Recruiting
      • Alaa Rahal
      • Contact: Ala Rahal, MSC pharm; Phone Number: 00974395897; Email: ARahhal1@hamad.qa
      • Contact: Alaa Rahal, MSC pharm; Phone Number: 00974395897; Email: ARahhal1@hamad.qa
      • Principal Investigator: Alaa Rahal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SGLT2 inhibitors users; Adults undergoing cardiothoracic surgery who had been using SGLT2 inhibitors for a minimum of 1 week before surgery, regardless of diabetes status	Drug: SGLT2 inhibitor; Dapagliflozin Empagliflzoin
SGLT2 inhibitors non-users; Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euglycemic diabetic ketoacidosis	Incidence of euglycemic diabetic ketoacidosis after surgery	1 month
Urinary tract infection	Incidence of urinary tract infection after surgery	1 month

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: MRC-01-23-470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No