NCT04806633

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1,722 (estimated)
• Sponsor: G.Gennimatas General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Left Cardiac Catheterization
• Percutaneous Coronary Intervention
• Acute Kidney Injury
• Sodium-glucose Co-transporter 2 Inhibitors

Interventions

Type	Name	Description
DRUG	Dapagliflozin 5mg	Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.
DRUG	Placebo	Patients randomized in this arm will receive placebo.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2021-03-19
• Last updated: 2021-03-19

Locations

2 sites across 1 country: Greece