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临床试验/NCT04806633
NCT04806633Unknown早期 1 期

Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention

G.Gennimatas General Hospital2 个研究点 分布在 1 个国家目标入组 1,722 人开始时间: 2021年4月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI

干预措施: Dapagliflozin 5mg (Drug)

Placebo

Placebo Comparator

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

发起方
G.Gennimatas General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Spyridon Deftereos

Professor

G.Gennimatas General Hospital

研究点 (2)

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