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

Sponsor
G.Gennimatas General Hospital
Study ID
NCT04806633
Phase
EARLY_PHASE1
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Mar 2021
Primary completion
Sep 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
1,722 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dapagliflozin
    Patients who will be randomized to receive dapagliflozin following cardiac catheterization and PCI
  • Placebo Comparator: Placebo
    Patients who will be randomized to receive placebo following cardiac catheterization and PCI

Primary Outcome Measure

Comparison of incidence of acute kidney injury (AKI) between the two study arms [ Time Frame: 1 month ]

Central Contacts

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