An observational study in Atrial Fibrillation, sponsored by Hamad Medical Corporation. Recruiting at 2 sites in Qatar. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Hamad Medical Corporation · Observational
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.
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).
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 3,280 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include 2 groups:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Adults not receiving SGLT2 inhibitors undergoing cardiothoracic surgery
Dapagliflozin Empagliflzoin
Incidence of post-operative atrial fibrillation (POAF)
Confirmed AF after surgery, regardless of frequency, duration, or intervention used for termination
Time frame: 1 month
Euglycemic diabetic ketoacidosis
Incidence of euglycemic diabetic ketoacidosis after surgery
Time frame: 1 month
Urinary tract infection
Incidence of urinary tract infection after surgery
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Dec 2024, 14 months after the start.
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