SGLT2 inhibitor TrEatment iN patients awaiting cOronary arTery bYpass surgery to reduce Post-opErative atrial fibrillation and kidney injury (STENOTYPE trial).

Phase 1

Recruiting

• Conditions: Onset of Atrial Fibrillation and Acute Kidney Injury after coronary artery bypass surgery (GABG); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-505375-75-00
• Lead Sponsor: Region Oerebro Laen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1)The subject has given their written consent to participate in the trial., 2)Subject is =18 years at the time of written consent., 3)Chronic coronary syndrome documented by coronary angiography, scheduled for CABG surgery with extra corporeal circulation. OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic valve replacement with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and mitral valve replacement or repair with extra corporeal circulation. AND/OR Patients with chronic coronary syndrome scheduled for CABG surgery with extra corporeal circulation and aortic root surgery with extra corporeal circulation.

Exclusion Criteria

1)Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment., 10)Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator’s clinical judgement., 11)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)., 12)Severe (estimated GFR < 25 mL/min/1.73 m2), unstable, or rapidly progressing renal disease at the time of enrolment., 13)CABG surgery planned within one week, 14)Emergency surgery with hemodynamic instability., 15)Previous history of AF., 16)Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile*) a.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 b. Who have a positive pregnancy test at enrolment or randomization, OR c. Who are breast-feeding., 17)Participation or recent participation in a clinical trial with an IMP within 30 days before randomization., 18)Previous randomization in the STENOTYPE trial., 19)Previous (within 30 days) or concomitant participation in another clinical trial with an investigational product. Registries and observational studies are allowed., 2)Intolerance, hypersensitivity, or other contraindications of dapagliflozin., 20)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., 3)Type 1 diabetes mellitus., 4)Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment., 5)Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment., 6)Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy., 7)Implantation or intent to implant a cardiac resynchronization device within 12 weeks prior to enrolment., 8)Stroke or transient ischemic attack within 12 weeks prior to enrolment., 9)Symptomatic bradycardia or second or third-degree atrioventricular block without pacemaker treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified