SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF
STENOTYPE
1 other identifier
interventional
800
3 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedStudy Start
First participant enrolled
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 4, 2028
April 8, 2025
April 1, 2025
3.7 years
April 24, 2023
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of new onset post-operative atrial fibrillation of at least 30 seconds
ECG or telemetry
From CABG to discharge post-operatively up to four weeks
Secondary Outcomes (18)
Acute kidney injury
From CABG to discharge post-operatively up to four weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Start of treatment until one-week post-discharge up to 26 weeks
All-cause mortality
From CABG to discharge post-operatively up to four weeks
New onset heart failure
From CABG to discharge post-operatively up to four weeks
Stroke
From CABG to discharge post-operatively up to four weeks
- +13 more secondary outcomes
Study Arms (2)
Active arm
ACTIVE COMPARATORTreatment with dapagliflozin 10 mg once daily.
Placebo arm
PLACEBO COMPARATORTreatment with matching placebo once daily.
Interventions
Dapagliflozin once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Matching placebo once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Current acute decompensated heart failure or hospitalization due to decompensated heart failure \<4 weeks prior to enrolment.
- Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy.
- Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment.
- Stroke or transient ischemic attack within 12 weeks prior to enrolment.
- Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment.
- Any condition such as, but not limited to, malignancy, with a life expectancy of \<2 years based on the investigator's clinical judgement.
- Hepatic impairment (aspartate transaminase or alanine transaminase \>3 × the upper limit of normal, or total bilirubin \>2 × upper limit of normal at the time of enrolment).
- Severe (estimated glomerular filtration rate \< 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment.
- CABG surgery planned within one week.
- Emergency surgery with hemodynamic instability.
- Previous history of AF.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- Odense University Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Örebro University, Swedencollaborator
- Sahlgrenska University Hospitalcollaborator
- Göteborg Universitycollaborator
- University of Leedscollaborator
- Skane University Hospitalcollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- St. Anne's University Hospital Brno, Czech Republiccollaborator
- Mount Sinai Hospital, New Yorkcollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- University Hospital, Linkoepingcollaborator
- Rigshospitalet, Denmarkcollaborator
Study Sites (8)
St. Anne University Hospital
Brno, Czechia
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
Aarhus, Denmark
Department of Cardiothoracic Surgery, Kobenhavn
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Sahlgrenska University Hospital
Gothenburg, Sweden
Linköping University Hospital
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Department of cardiology
Örebro, 70185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Björkenheim, MD, PhD
VO Hjärt- lungmedicin och klinisk fysiologi USÖ
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, care providers, investigators and outcomes assessors are all blinded to treatment allocation.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 10, 2023
Study Start
April 4, 2024
Primary Completion (Estimated)
December 4, 2027
Study Completion (Estimated)
December 4, 2028
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available upon reasonable request starting after the publication of the main results and will remain available for 5 years.
- Access Criteria
- Access to the anonymized dataset will be granted upon request to qualified researchers who provide a methodologically sound proposal. The proposal must be approved by the study's principal investigator and a data access agreement must be signed.
Demographic Data: Age, sex, ethnicity. Baseline Data: Initial health status, medical history. Outcome Data: Primary and secondary outcomes measured during the trial. Adverse Events: Any side effects or adverse events recorded. Follow-up Data: Information collected during follow-up.