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

NCT06251453 | Unknown

• 1 other identifier: MRC-01-23-470
• Study Type: observational
• Target: 3,280
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of post-operative atrial fibrillation (POAF)

  Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination

  1 month

Secondary Outcomes (2)

• Euglycemic diabetic ketoacidosis

  1 month

• Urinary tract infection

  1 month

Study Arms (2)

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

SGLT2 inhibitors non-users

Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery

Interventions

SGLT2 inhibitor DRUG

Dapagliflozin Empagliflzoin

SGLT2 inhibitors users

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (2)

Alaa Rahal

Doha, DA, 3050, Qatar

RECRUITING

Hamad medical corporation

Doha, DA, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Central Study Contacts

Alaa Rahhal, Msc

CONTACT

55712353; ARahhal1@hamad.qa

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: February 9, 2024
• Study Start: October 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: February 9, 2024

Record last verified: 2023-09

Locations

QA (2)