Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 1,722
- 试验地点
- 2
- 主要终点
- Comparison of incidence of acute kidney injury (AKI) between the two study arms
研究概览
简要总结
Left heart catheterization and percutaneous coronary intervention (PCI) has become a useful tool in interventional cardiology, in which iodinated contrast media is used. Although the use of iodinated contrast media (CM) is considered to be safe in patients with normal renal function, it is risky in patients with known chronic renal insufficiency (CKD) and diabetes mellitus. Contrast induced nephropathy (CIN) remains one of the most leading causes of in hospital acute kidney injury (AKI), affecting morbidity and mortality. There are various mechanisms through which CM develop their nephrotoxic effects, including renal vasoconstriction and medullary hypoxia, tubular cell toxicity and reactive oxygen species formation.
Inhibitors of type 2 sodium- glucose co-transporter (SGLT2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. However, although SGLT2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. Moreover, pleiotropic effects have been observed, including a reno-protective action. In addition to the effects mediated by intrarenal hemodynamic changes, SGLT2-i also have direct anti-inflammatory and antifibrotic nephroprotective effects. Indeed, SGLT2-i suppress the production of reactive oxygen species, lessening glomerulosclerosis and tubulo-interstitial fibrosis.
These findings suggest that the use of SGLT2i could offer benefit by reducing/ preventing the nephrotoxic effects of contrast media leading to the assumption that the use of these drugs could prevent the incidence nephropathy after cardiac catheterization and percutaneous coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Written informed consent
- •Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
- •Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
排除标准
- •Active malignancy
- •Participation in other intervention study
- •Class I or equivalent indication for treatment with a SGLT2 inhibitor
- •Pregnancy or willing of pregnancy during the follow up period
- •Active urogenital infection
- •Diabetes mellitus type 1
- •History of diabetic ketoacidosis
- •Cardiogenic shock
- •eGFR < 29 ml/min/1.73m2
- •Patients with an indication for SGLT2 inhibitor will be included in a prospective registry. Their treatment will be determined by their attending physicians.
研究组 & 干预措施
Dapagliflozin
Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI
干预措施: Dapagliflozin 5mg (Drug)
Placebo
Patients who will be randomized to receive placebo following cardiac catheterization and PCI
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of incidence of acute kidney injury (AKI) between the two study arms
时间窗: 1 month
AKI is defined defined as an absolute creatinine level increase of at least 0.3 mg/dL (≥26.5 μmol/L) or at least 1.5-fold from baseline.
次要结局
- Development of at least Stage 2 AKI (according to the KDIGO criteria), i.e. Increase in sCR>2.0-fold from baseline.(1 month)
研究者
Spyridon Deftereos
Professor
G.Gennimatas General Hospital
