RecruitingPhase 3NCT05852704

SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF

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


Sponsor

Region Örebro County

Enrollment

800 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diabetes medication called an SGLT2 inhibitor (dapagliflozin) — which is known to protect the heart — can reduce the risk of developing an irregular heart rhythm called atrial fibrillation (AF) after heart bypass surgery. **You may be eligible if...** - You are 18 or older - You are scheduled for elective (planned, non-emergency) coronary artery bypass graft (CABG) surgery, possibly combined with valve surgery **You may NOT be eligible if...** - You have taken an SGLT2 inhibitor within the past 8 weeks or plan to take one - You have Type 1 diabetes - You have very low blood pressure (systolic below 95 mmHg) - You recently had acute heart failure, a stroke, or a mini-stroke (TIA) within 12 weeks - You have certain serious heart conditions such as hypertrophic cardiomyopathy or uncontrolled arrhythmia - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10mg Tab

Dapagliflozin once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.

DRUGPlacebo Tab

Matching placebo once daily for a minimum of seven days while awaiting scheduled CABG and up until discharge with a short interruption for surgery.


Locations(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, Sweden

View Full Details on ClinicalTrials.gov

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NCT05852704


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