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

Early Phase 1

• Conditions: Left Cardiac Catheterization; Percutaneous Coronary Intervention; Sodium-glucose Co-transporter 2 Inhibitors; Acute Kidney Injury
• Interventions: Drug: Dapagliflozin 5mg; Drug: Placebo

• Registration Number: NCT04806633
• Lead Sponsor: G.Gennimatas General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19
• Study Start: 2021-04-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1722

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin 5mg	Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI
Placebo	Placebo	Patients who will be randomized to receive placebo following cardiac catheterization and PCI

Primary Outcome Measures

Name	Time	Method
Comparison of incidence of acute kidney injury (AKI) between the two study arms	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.

Secondary Outcome Measures

Name	Time	Method
Development of at least Stage 2 AKI (according to the KDIGO criteria), i.e. Increase in sCR>2.0-fold from baseline.	1 month

Trial Locations

Locations (2)

Cardiology Department, Athens General Hospital "G. Gennimatas"; 🇬🇷 Athens, Greece

2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.; 🇬🇷 Athens, Greece