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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Örebro County

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Dapagliflozin 10mg Tab
  • Placebo Tab

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Region Örebro County

Lead sponsor

Odense University Hospital

Collaborator

Aarhus University Hospital

Collaborator

Örebro University, Sweden

Collaborator

Sahlgrenska University Hospital

Collaborator

Göteborg University

Collaborator

University of Leeds

Collaborator

Skane University Hospital

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator

St. Anne's University Hospital Brno, Czech Republic

Collaborator

Mount Sinai Hospital, New York

Collaborator

Icahn School of Medicine at Mount Sinai

Collaborator

University Hospital, Linkoeping

Collaborator

Rigshospitalet, Denmark

Collaborator