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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
RECRUITING
Aarhus
Department of Cardiothoracic Surgery, Kobenhavn
NOT_YET_RECRUITING
Copenhagen
Odense University Hospital
NOT_YET_RECRUITING
Odense
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Skane University Hospital
RECRUITING
Lund
Department of cardiology
RECRUITING
Örebro
Contact Information
Primary
Anna Björkenheim, MD, PhD
anna.bjorkenheim@regionorebrolan.se
0046196025459
Backup
Ole Fröbert, MD, PhD
ole.frobert@regionorebrolan.se
0046196025413
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2028-12-04
Participants
Target number of participants: 800
Treatments
Active_comparator: Active arm
Treatment with dapagliflozin 10 mg once daily.
Placebo_comparator: Placebo arm
Treatment with matching placebo once daily.
Sponsors
Collaborators: University of Leeds, Icahn School of Medicine at Mount Sinai, Odense University Hospital, Skane University Hospital, Aarhus University Hospital, London School of Hygiene and Tropical Medicine, Mount Sinai Hospital, New York, University Hospital, Linkoeping, Göteborg University, St. Anne's University Hospital Brno, Czech Republic, Örebro University, Sweden, Sahlgrenska University Hospital, Rigshospitalet, Denmark
Leads: Region Örebro County

This content was sourced from clinicaltrials.gov