2023-505375-75-00招募中3 期
SGLT2 inhibitor TrEatment iN patients awaiting cOronary arTery bYpass surgery to reduce Post-opErative atrial fibrillation and kidney injury (STENOTYPE trial).
Region Oerebro Laen8 个研究点 分布在 3 个国家目标入组 800 人开始时间: 2024年1月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- AF lasting at least 30 seconds as detected on ECG or telemetry in-hospital after CABG surgery.
研究概览
简要总结
To establish the efficacy of dapagliflozin in reducing the incidence of new onset post-operative AF during hospitalization following CABG.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial.
- •Subject is ≥18 years at the time of written consent.
- •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.
排除标准
- •Treatment with an SGLT2 inhibitor within 8 weeks prior to enrolment or planned treatment.
- •Any condition such as, but not limited to, malignancy, with a life expectancy of <2 years based on the investigator’s clinical judgement.
- •Known hepatic impairment.
- •Severe (estimated GFR < 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*) 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.
- •Participation or recent participation in a clinical trial with an IMP 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.
- •Intolerance, hypersensitivity, or other contraindications of dapagliflozin.
- •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.
- •Type 1 diabetes mellitus.
- •Symptomatic hypotension or systolic blood pressure <95 mmHg at two out of three measurements at enrolment.
- •Current acute decompensated HF or hospitalization due to decompensated HF <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.
结局指标
主要结局
AF lasting at least 30 seconds as detected on ECG or telemetry in-hospital after CABG surgery.
AF lasting at least 30 seconds as detected on ECG or telemetry in-hospital after CABG surgery.
次要结局
- AKI, as defined by at least a 1.5-fold increase from baseline in serum creatinine within the prior seven days, an absolute increase in serum creatinine of 26.5 µmol/L or more within 48 hours, 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. This condition is monitored in-hospital after CABG surgery.
- Safety and tolerability of dapagliflozin. Reported AEs, SAEs, and SUSAR from start of treatment until one-week post-discharge.
- All-cause mortality.
- Stroke.
- New onset heart failure.
- Ventricular arrhythmia.
- Electrical cardioversion for AF.
- Use of amiodarone for AF.
- Change in inflammatory and cardiac biomarkers from baseline to end of CABG surgery, 6±2 hours, 12±2 hours, and three days after CABG surgery.
- Change in HbA1c from baseline to three days after CABG surgery.
- Length of intensive care unit and hospital stay.
- 30-day all-cause mortality.
- 12-month all-cause mortality
- 12-month myocardial infarction.
- 12-month stroke.
- 12-month hospital admission for AF or heart failure.
- 12-month dialysis treatment.
研究者
Anna Björkenheim
Scientific
Region Oerebro Laen
研究点 (8)
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