Ireland
--:--IST
Recruiting Phase 3

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

NCT05852704 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 3
Started
2024-04-04
Last updated
2025-04-08

Condition(s) studied

Chronic Coronary SyndromeAtrial Fibrillation

Investigational drug(s) / intervention(s)

Dapagliflozin 10mg Tab →Placebo Tab

Dapagliflozin 10mg Tab: Dapagliflozin once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.

Placebo Tab: Matching placebo once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment. * Intolerance, hypersensitivity, or other contraindications of dapagliflozin. * Type 1 diabetes mellitus. * Symptomatic hypotension or systolic blood pressure \<95 mmHg at two out of three measurements at enrolment. * Current acute decompensated heart failure or hospitalization due to decompensated heart failure \<4 weeks prior to enrolment. * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy. * 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. * Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment. * Any condition such as, but not limited to, malignancy, with a life expectancy of \<2 years based on the investigator's clinical judgement. * 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). * Severe (estimated glomerular filtration rate \< 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment. * CABG surgery planned within one week. * Emergency surgery with hemodynamic instability. * Previous history of AF. * Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile\*) 1. 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 2. Who have a positive pregnancy test at enrolment or randomization, OR 3. Who are breast-feeding. * 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. * 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.

Primary outcome measure(s)

  • Incidence of new onset post-operative atrial fibrillation of at least 30 seconds — From CABG to discharge post-operatively up to four weeks
    ECG or telemetry

Trial sites (8)

FacilityCityRegionStatus
St. Anne University Hospital Brno Czechia Not Yet Recruiting
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark Aarhus Denmark Recruiting
Department of Cardiothoracic Surgery, Kobenhavn Copenhagen Denmark Not Yet Recruiting
Odense University Hospital Odense Denmark Not Yet Recruiting
Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Linköping University Hospital Linköping Sweden Not Yet Recruiting
Skane University Hospital Lund Sweden Recruiting
Department of cardiology Örebro Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05852704 on ClinicalTrials.gov ↗ ← All trials in Denmark