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

NCT ID: NCT06251453

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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).

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

SGLT2 inhibitor

Intervention Type DRUG

Dapagliflozin Empagliflzoin

SGLT2 inhibitors non-users

Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery

No interventions assigned to this group

Interventions

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SGLT2 inhibitor

Dapagliflozin Empagliflzoin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamad Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaa Rahal

Doha, DA, Qatar

Site Status RECRUITING

Hamad medical corporation

Doha, DA, Qatar

Site Status RECRUITING

Countries

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Qatar

Central Contacts

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Alaa Rahhal, Msc

Role: CONTACT

Facility Contacts

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Ala Rahal, MSC pharm

Role: primary

00974395897

Alaa Rahal, MSC pharm

Role: backup

00974395897

Alaa Rahal, Msc Pharma

Role: primary

Other Identifiers

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MRC-01-23-470

Identifier Type: -

Identifier Source: org_study_id

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