Actively Recruiting
SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF
Led by Region Örebro County · Updated on 2025-04-08
800
Participants Needed
8
Research Sites
243 weeks
Total Duration
On this page
Sponsors
R
Region Örebro County
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Patients aged 18 years or older
- Chronic coronary syndrome scheduled for elective isolated CABG surgery with extracorporeal circulation, or elective CABG surgery combined with aortic valve replacement, mitral valve surgery, and/or aortic root surgery
You will not qualify if you...
- Treatment with an SGLT2 inhibitor within 8 weeks prior to enrollment or planned treatment
- Intolerance, hypersensitivity, or other contraindications to dapagliflozin
- Type 1 diabetes mellitus
- Symptomatic hypotension or systolic blood pressure below 95 mmHg at two of three measurements at enrollment
- Current acute decompensated heart failure or hospitalization for decompensated heart failure within 4 weeks prior to enrollment
- Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy
- Implantation or planned implantation of a cardiac resynchronization device within 12 weeks prior to enrollment
- Stroke or transient ischemic attack within 12 weeks prior to enrollment
- Symptomatic bradycardia or second- or third-degree atrioventricular block without pacemaker treatment
- Life expectancy less than 2 years due to any condition including malignancy, according to investigator judgment
- Hepatic impairment with elevated liver enzymes or bilirubin above defined limits at enrollment
- Severe, unstable, or rapidly progressing renal disease with estimated glomerular filtration rate under 25 mL/min/1.73 m2 at enrollment
- CABG surgery planned within one week
- Emergency surgery with hemodynamic instability
- Previous history of atrial fibrillation
- Women of childbearing potential who are not willing to use highly effective contraception, have a positive pregnancy test, or are breastfeeding
- Participation in another clinical trial with an investigational drug within 30 days before randomization
- Previous randomization in this trial
- Mental inability, reluctance, or language difficulties that impair understanding of trial participation, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 8 locations
1
St. Anne University Hospital
Brno, Czechia
Not Yet Recruiting
2
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
Aarhus, Denmark
Actively Recruiting
3
Department of Cardiothoracic Surgery, Kobenhavn
Copenhagen, Denmark
Not Yet Recruiting
4
Odense University Hospital
Odense, Denmark
Not Yet Recruiting
5
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
6
Linköping University Hospital
Linköping, Sweden
Not Yet Recruiting
7
Skane University Hospital
Lund, Sweden
Actively Recruiting
8
Department of cardiology
Örebro, Sweden, 70185
Actively Recruiting
Research Team
A
Anna Björkenheim, MD, PhD
CONTACT
O
Ole Fröbert, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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