SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

A vizsgálat adatai

Ki végzi

Region Örebro County

Azonosító

NCT05852704EU 2023-505375-75-00

A regiszteradat frissítve

2025. április 8.

Eredeti leírás

The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are:A teljes eredeti leírásKevesebb

SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative Atrial Fibrillation and Kidney Injury (STENOTYPE Trial)

The goal of this randomized, double-blinded, controlled clinical trial is to investigate if treatment with an sodium-glucose cotransporter-2 inhibitor (SGLT2) during the unique time window before coronary artery bypass surgery (CABG), can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury in patients with chronic coronary syndrome. The main questions it aims to answer are:

* Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of new onset atrial fibrillation compared to placebo? * Does treatment with an SGLT2 inhibitor during the waiting time and stable post-operative period, in patients with chronic coronary syndrome scheduled for CABG, reduce the risk of acute kidney injury before hospital discharge compared to placebo?

Participants will be administered dapagliflozin 10 mg once daily or placebo for a minimum of seven days while awaiting scheduled CABG and up until discharge, with a short interruption for surgery. The active arm will be compared to the placebo arm to see if dapagliflozin can reduce the incidence of post-operative atrial fibrillation and/or acute kidney injury.

Bevonási feltételek: Written informed consent; Patients aged 18 years or older; Chronic coronary syndrome scheduled for elective isolated CABG surgery with extra corporeal circulation, or elective CABG surgery with extra corporeal circulation combined with aortic valve replacement, mitral valve surgery, and / or aortic root surgery.

Kizáró feltételek: Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment; Current acute decompensated heart failure or hospitalization due to decompensated heart failure <4 weeks prior to enrolment; Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment; Stroke or transient ischemic attack within 12 weeks prior to enrolment; CABG surgery planned within one week; Emergency surgery with hemodynamic instability; Previous history of AF; Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days before randomization; Previous randomization in the STENOTYPE trial; Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed; Intolerance, hypersensitivity, or other contraindications of dapagliflozin; Type 1 diabetes mellitus; Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy; Severe (estimated glomerular filtration rate < 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment; Hepatic impairment (aspartate transaminase or alanine transaminase >3 × the upper limit of normal, or total bilirubin >2 × upper limit of normal at the time of enrolment); Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator's clinical judgement; Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment; Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment; Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile*); Who are not willing to use a highly effective method of contraception** judged by the investigator, from the time of signing the informed consent throughout the trial and 4 weeks thereafter, OR; Who have a positive pregnancy test at enrolment or randomization, OR; Who are breast-feeding; Mental inability, reluctance, or language difficulties of the subject, in the opinion of the investigator, that result in difficulty in understanding the meaning of participation in the trial.

ClinicalTrials.gov NCT05852704 · EU CTIS 2023-505375-75-00