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

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.

Conditions

• Chronic Coronary Syndrome
• Atrial Fibrillation

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Örebro University, Sweden

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• St. Anne's University Hospital Brno, Czech Republic

  collaborator OTHER

• Mount Sinai Hospital, New York

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Region Örebro County

  lead OTHER

Principal Investigators

• Anna Björkenheim, MD, PhD · VO Hjärt- lungmedicin och klinisk fysiologi USÖ

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-04

Primary Completion

2027-12-04

Completion

2028-12-04

Countries

• Czechia
• Denmark
• Sweden

Study Locations