Using SGLT2 inhibitors to prevent heart rhythm issues and kidney injury before heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether administering dapagliflozin, an SGLT2 inhibitor, can reduce the incidence of post-operative atrial fibrillation and acute kidney injury in patients with chronic coronary syndrome awaiting coronary artery bypass surgery (CABG). The study is a multicenter, randomized, double-blinded, controlled trial involving 800 participants who will receive either dapagliflozin or a placebo for at least seven days prior to surgery. The primary endpoint is the occurrence of new onset atrial fibrillation during hospitalization after CABG, while secondary endpoints include the incidence of acute kidney injury. Participants will be monitored for safety and outcomes through national registries for up to 12 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile\*)

  1. Who are not willing to use a highly effective method of contraception\*\* judged by the investigator, from the time of signing the informed consent throughout the trial and 4 weeks thereafter, OR
  2. Who have a positive pregnancy test at enrolment or randomization, OR
  3. Who are breast-feeding.
* Participation or recent participation in a clinical trial with an investigational medicinal product within 30 days before randomization.
* Previous randomization in the STENOTYPE trial.
* Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed.
* Mental inability, reluctance, or language difficulties of the subject, in the opinion of the investigator, that result in difficulty in understanding the meaning of participation in the trial.

Where it's running

• Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
  Aarhus, Denmark Recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Skane University Hospital
  Lund, Sweden Recruiting
• Department of cardiology
  Örebro, Sweden Recruiting
• St. Anne University Hospital
  Brno, Czechia Not yet recruiting
• Department of Cardiothoracic Surgery, Kobenhavn
  Copenhagen, Denmark Not yet recruiting

Study contacts

• Principal investigator: Anna Björkenheim, MD, PhD — VO Hjärt- lungmedicin och klinisk fysiologi USÖ
• Study coordinator: Anna Björkenheim, MD, PhD
• Email: anna.bjorkenheim@regionorebrolan.se
• Phone: 0046196025459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.