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

G.Gennimatas General Hospital

Status and phase: Unknown; Early Phase 1

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

Treatments: Drug: Placebo; Drug: Dapagliflozin 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04806633

2663

Details and patient eligibility

About

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.

Enrollment: 1,722 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,722 participants in 2 patient groups, including a placebo group

Dapagliflozin

Active Comparator group

Description:

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

Treatment:

Drug: Dapagliflozin 5mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo