A clinical trial of Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention begins in Greece

G.Gennimatas General Hospital is recruiting patients for the clinical trial of Dapagliflozin to Prevent the Incidence of Contrast Induced Nephropathy After Heart Catheterization and Percutaneous Coronary Intervention.

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.

The researchers plan that April 1, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in December 1, 2023.

The study will take place at the Cardiology Department, Athens General Hospital "G. Gennimatas", Athens and 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.

There are a number of conditions that do not allow participation, such as:

  • 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.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04806633

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