2025-524395-30-00招募中4 期
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes – DISCO Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 458
- 试验地点
- 4
- 主要终点
- composite endpoint, describing postoperative cardiovascular outcomes, namely: – Perioperative myocardial injury within the first 48 hours postoperatively, defined by an increase in high-sensitivity troponin I (HS). – Low cardiac output syndrome within 7 days postoperatively – Rehospitalisation at 30 days postoperatively for left heart failure – All-cause mortality at 30 days postoperatively.
研究概览
简要总结
The primary objective will be to demonstrate the superiority of continuing SGLT-2 inhibitors preoperatively until the morning of surgery versus discontinuing SGLT-2 inhibitors 3 days prior to surgery, on the 30-day cardiovascular outcome of patients with heart failure and impaired ejection fraction who have been treated for at least 4 weeks with SGLT-2 inhibitors and who are undergoing scheduled cardiac surgery with cardiopulmonary bypass.
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
- •Adult patients scheduled to undergo cardiac surgery with cardiopulmonary bypass
- •patients treated with SGLT-2 inhibitors, including combined treatment with metformin, for at least 4 weeks
- •heart failure patients with a left ventricular ejection fraction strictly below 50%
- •patients who have signed the informed consent form
- •patients enrolled in a social security scheme or equivalent
排除标准
- •Treatment with SGLT-2i introduced less than 4 weeks ago or with SGLT-2i other than empagliflozin or dapagliflozin
- •Patients on preoperative mechanical circulatory support
- •Heart transplant surgery or LVAD (Left Ventricular Assist Device) implantation
- •Patients with chronic renal failure with a glomerular filtration rate below 25 mL/min/1.73 m2
- •Acute conditions likely to call into question the continuation of SGLT2 inhibitor therapy (alone or in combination) at the time of inclusion, including in particular: shock state or acute tissue hypoxia (episode of hyperlactatemia > 3 mmol/L within 7 days prior to inclusion); acute kidney injury within the previous 7 days (KDIGO stage ≥2); severe hepatocellular failure (factor V level < 50%); acute alcohol intoxication within the previous 7 days or active alcohol use disorder without withdrawal.
- •Patients with heart failure and preserved ventricular ejection fraction greater than or equal to 50%
- •Pregnant or breastfeeding women
- •Patients with a contraindication to the use of SGLT2 inhibitors: type 1 diabetes, known hypersensitivity, chronic kidney disease with an eGFR of less than 25 ml/min/1.73 m²
- •Minors or adult patients under protective measures (guardianship, trusteeship, or judicial protection)
- •Patients who do not understand or speak French.
- •Patients participating in another interventional study
- •Surgery within less than 3 days
- •Surgery for active endocarditis lasting less than 3 months
结局指标
主要结局
composite endpoint, describing postoperative cardiovascular outcomes, namely: – Perioperative myocardial injury within the first 48 hours postoperatively, defined by an increase in high-sensitivity troponin I (HS). – Low cardiac output syndrome within 7 days postoperatively – Rehospitalisation at 30 days postoperatively for left heart failure – All-cause mortality at 30 days postoperatively.
composite endpoint, describing postoperative cardiovascular outcomes, namely: – Perioperative myocardial injury within the first 48 hours postoperatively, defined by an increase in high-sensitivity troponin I (HS). – Low cardiac output syndrome within 7 days postoperatively – Rehospitalisation at 30 days postoperatively for left heart failure – All-cause mortality at 30 days postoperatively.
次要结局
- All-cause mortality a) at 30 days b) at 7 days
- Euglycaemic ketoacidosis defined by a pH < 7.35 and the presence of capillary ketonemia > 0.6 mmol/l and capillary blood glucose < 2.5 g/l within 7 days post-operatively.
- Postoperative myocardial injury within the first 48 hours after surgery, defined by an increase in high-sensitivity troponin I (HS). The thresholds will be 218 times the laboratory threshold value for patients undergoing coronary artery bypass grafting or aortic valve replacement or repair surgery. For patients undergoing other types of cardiac surgery, the threshold will be 499 times the laboratory threshold value.
- Postoperative low cardiac output syndrome occurring within 7 days postoperatively, defined by infusion of positive inotropes for more than 48 hours and/or the need for temporary mechanical circulatory support postoperatively (ECLS, CPIA, Impella®).
- Rehospitalisation within 30 days of surgery for left heart failure defined by the need for introduction or increase in diuretics and/or administration of positive inotropes and/or use of invasive or non-invasive ventilation for acute pulmonary oedema. Only stays in cardiology departments, including intensive care, cardiac surgery or resuscitation, will be considered.
- Acute renal failure defined as a KDIGO (Kidney Disease Improving Global Outcome) score ≥ 2, occurring in intensive care within 7 days.
- The delay in days before postoperative resumption of SGLT-2 inhibitors
- Quality of life will be assessed using an EQ5D test carried out the day before surgery and on day 30.
- Length of stay in intensive care in days
- Length of hospital stay in days
研究者
Principal investigator
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (4)
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