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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Dapagliflozin 10mg Tab
DrugDapagliflozin once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Placebo Tab
DrugMatching placebo once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: Active armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of new onset post-operative atrial fibrillation of at least 30 seconds
ECG or telemetry
Time frame
From CABG to discharge post-operatively up to four weeksSecondary outcomes
1
Acute kidney injury
Defined as at least a 1.5-fold increase from baseline in serum creatinine within the prior 7 days, an absolute increase in serum creatinine of 26.5 µmol/L, or a urine volume of less than 0.5 mL/kg/h for at least six hours, following Kidney Disease Improving Global Outcomes grade 1 or above before discharge. Key secondary outcome.
Time frame
From CABG to discharge post-operatively up to four weeks2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Reported AEs, SAEs, and SUSAR
Time frame
Start of treatment until one-week post-discharge up to 26 weeks3
All-cause mortality
Death
Time frame
From CABG to discharge post-operatively up to four weeks4
New onset heart failure
Diagnosis of heart failure for the first time.
Time frame
From CABG to discharge post-operatively up to four weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov